CN110967512A - Measuring apparatus and accuracy control method - Google Patents
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Abstract
The invention discloses a measuring device and a precision management method. The technical problem of accuracy management is solved by a measuring device, comprising: the measurement device includes a measurement unit that measures a management sample for performing quality control, a display unit, and a processing unit that displays an input interface for setting an evaluation criterion used for the quality control on the display unit, wherein the processing unit displays a quality control result of an inspection item on the display unit based on a measurement result of the management sample and the evaluation criterion.
Description
Technical Field
The present disclosure relates to a measurement device and a precision management method.
Background
In the cell analysis using the particle analyzer, when the same detection reagent is used for the same cell, it is required that the measurement results match between analyses performed independently on different dates and times. In particular, in clinical cytological analysis and examination for processing clinical specimens, internal accuracy control is required to maintain analysis accuracy (non-patent document 1).
The internal accuracy management is performed to monitor the reproducibility and variation of the analysis. This reproducibility monitoring is performed by measuring a control sample such as a quality control sample sold on the market and a quality control sample collected at each facility before measuring a normal clinical sample.
Documents of the prior art
Non-patent document
Non-patent document 1: flow Cytometry checklists (Flow Cytometry checklist, 07.28.2015, FLO.23737 QC-Reagents/Stain Phase II);
non-patent document 2: beckman coulter (Beckman coulter) corporation, for precision management entry to FCM: 1. internal quality management by managing samples (https://www.bc-cytometry.com/QC/QC-4-1.html）。
Disclosure of Invention
Technical problem to be solved by the invention
In a measurement device for performing a sample test, since reproducibility is required for measurement when the same sample is measured, precision control of measurement precision is required. In particular, in a particle analyzer such as a flow cytometer, when detecting a plurality of antigens and nucleic acids in 1 examination, a cell sample including the following substances is generally used as a control sample in internal accuracy control: beads having the same fluorescence wavelength as the fluorescent dye used for labeling the cells to be examined, living cells of the same cell type or cell system as the cells to be examined, or cells obtained by fixing and storing living cells. An accuracy control sample is commercially available for an examination item with a high frequency of requested examinations, particularly an examination item using a reagent for in vitro diagnosis. However, an inspection item with a low frequency of requested inspection, particularly a control sample for performing precision control of a reagent for investigation, is not generally marketed.
In the united states, as shown in non-patent document 1, it is also obligated to perform internal accuracy control with respect to such inspection items that do not provide a control sample. Therefore, when the control sample is not commercially available, it is necessary to prepare a sample for quality control in each inspection room.
In addition, the quality control is generally performed on a daily, weekly, or monthly basis for the examination, or on a reagent lot basis. Therefore, when a control sample is supplied, control information such as how much the detection sensitivity of the measurement device should be maintained and how much the measurement conditions such as how to perform fluorescence correction should be maintained when measuring the control sample is generally supplied from the provider of the control sample or the provider of the measurement device. In this case, the allowable range of accuracy, that is, the evaluation criterion-related information is also provided together with the control sample. However, when the management sample is not supplied from the provider of the management sample or the provider of the measurement device, evaluation criteria for precision management must be set in each examination room.
In general, in a particle analyzer, the results of measuring a commercially available control sample are rarely managed by a system for controlling the particle analyzer, and in a control system attached to the particle analyzer, monitoring over time cannot be performed in accordance with a user request. Conventionally, management of monitoring results of samples has been performed by creating a management chart such as an Xbar-R management chart in Excel (registered trademark) or the like. However, the work of creating such a management chart and determining and reading the accuracy management information from the management chart is always dependent on the experience of a user who is skilled in the particle analysis.
In the present disclosure, one technical problem is that: as described above, when the user sets the evaluation criterion of the quality control according to the inspection item in the measurement device, the quality control is assisted. In addition, the technical problem is that: the assistance is performed so that the accuracy of the measurement device can be managed without depending on the expertise of the user involved in the cell analysis.
Means for solving the problems
One embodiment of the present disclosure relates to a measurement device (1000), the measurement device (1000) including: the measurement unit (200) for measuring a management sample for performing quality control, the display unit (17), and the processing unit (10) for displaying an input interface for setting an evaluation criterion used for the quality control on the display unit (17), wherein the processing unit (10) displays a quality control result of the inspection item on the display unit (17) based on a measurement result of the management sample and the evaluation criterion. According to the embodiment, the accuracy management result can be displayed on a display unit (17) connected to a control unit (100) of a measurement device (1000). This can improve the quality of measurement data, reduce management cost, and shorten service time.
Preferably: the evaluation criterion is set according to the examination item. This embodiment enables quality control according to the inspection items.
Preferably: the evaluation criterion is set by a user. With this embodiment, it is possible to perform precision management with respect to an inspection item desired by a user.
Preferably: the evaluation criterion is stored in a storage unit of the particle analysis device (1000) in a format that can be read by a processing unit (10) of the particle analysis device (1000). According to the embodiment, the evaluation criterion of the precision management can be exported to the application software of the measuring device (1000).
Preferably: the measurement device (1000) further comprises an input unit for setting the evaluation criterion on the input interface. This embodiment can assist the user in setting the evaluation criterion.
Preferably: the particles are cells, and the test item corresponds to a cell to be measured. More preferably: the target molecule is an antigen. This embodiment enables the control unit (100) to perform the accuracy control of the cell analysis.
Preferably: the inspection items include 1 or more kinds of measurement items, and the evaluation criterion is set for each measurement item. More preferably: the measurement items include detection items corresponding to 2 or more types of target molecules to be detected that are individually detected by different light receiving elements. This embodiment enables setting of a progress evaluation criterion for each measurement item (subsetpanel).
Preferably: the evaluation criterion is determined based on the intensity of the light detected by each light receiving element. With this embodiment, the evaluation criterion can be set based on the histogram.
Preferably: the evaluation criterion was set based on a particle distribution map developed from the intensities of light of 2 measurement items. This embodiment enables setting of an evaluation criterion on the scattergram. Preferably: the evaluation criterion is set based on a certain gate (gate). More preferably: the gate is set by the user. This embodiment makes it possible to set a rating standard in a fixed gate (gate).
Preferably: the evaluation criterion includes upper and lower limits of the intensity of light or particle size. With this embodiment, an evaluation criterion can be set based on the intensity of light or particle size.
Preferably: the evaluation criterion is set based on statistical information. More preferably: the statistical information is selected from the number of cells within the gate (gate), the median of the intensity of the light, the average of the intensity of the light, or the standard deviation of the intensity of the light. With this embodiment, evaluation criteria can be set based on various statistical information.
Preferably: and displaying at least 1 selected from an input area for accepting characters input by a user, an icon for accepting user selection and a drop-down list for accepting user selection on the input interface. User usability can be improved by this embodiment.
Preferably: and displaying the histogram or the scatter diagram on the input interface. With this embodiment, the user can set the evaluation criterion while viewing the histogram or scatter diagram displayed on the input interface.
Preferably: the character string corresponding to each light-receiving element is displayed on the input interface. With this embodiment, evaluation criteria can be set for each light receiving element.
Preferably: the light is fluorescent and/or scattered light. In this embodiment, evaluation criteria can be set for fluorescence, scattered light, and the like.
Preferably: when the light is fluorescence and there are several light receiving elements having sensitivity to 1 type of fluorescence, the processing unit (10) further sets a fluorescence correction condition for adjusting the sensitivity of the several light receiving elements when setting the evaluation criterion. In this embodiment, when fluorescence of a plurality of wavelengths is used, fluorescence correction can be automatically performed.
Preferably: the particle analysis apparatus (1000) is a flow cytometer. With this embodiment, in a flow cytometer, particularly a multicolor flow cytometer, evaluation criteria can be set.
Preferably: the result of the quality control is displayed every time a control sample for each quality control is measured. By the implementation, the accuracy management result can be monitored in real time.
Preferably: the result of the quality control is a result of the quality control for each channel, and is displayed in a graph developed with a plurality of channels as axes. By the implementation, the precision management results of a plurality of channels can be displayed on 1 interface.
Preferably: the result of the quality control is displayed together with the result of the quality control at a point in time performed in the past. More preferably: the results of the quality management are shown in a time series chart. With this embodiment, the change within one day and the change between days of the quality control result can be grasped at a glance.
Preferably: when the result of the quality control is bad, a warning is displayed together with the result of the quality control. With this embodiment, the user can grasp the accuracy management abnormality as early as possible.
One embodiment of the present disclosure relates to a precision management method including: the method includes a display step of displaying an input interface for setting an evaluation criterion corresponding to an inspection item, a measurement step of measuring a control sample for quality control based on the evaluation criterion, and an output step of outputting a quality control result of the control sample measured in the measurement step. According to the present embodiment, the accuracy management result can be displayed on the display unit 17 connected to the control unit (100) of the measurement device (1000). Therefore, the quality of the measurement data can be improved, the management cost can be reduced, and the service time can be shortened.
Preferably: in the precision management method, the evaluation criterion is set according to the inspection item. This embodiment enables quality control according to the inspection items.
Preferably: in the precision management method, the evaluation criterion is set by a user. With this embodiment, it is possible to perform precision management with respect to an inspection item desired by a user.
Preferably: in the accuracy management method, the inspection items include 1 or more measurement items, and the evaluation criterion is set for each measurement item. More preferably: the measurement items include measurement items corresponding to 2 or more target molecules to be measured that are measured by different light receiving elements individually. In this embodiment, evaluation criteria can be set for each measurement item (subset panel).
Preferably: in the accuracy control method, the evaluation criterion is determined based on the intensity of light measured by each light receiving element. With this embodiment, the evaluation criterion can be set based on the histogram.
Preferably: in the accuracy control method, the evaluation criterion is set based on a particle distribution map developed from the intensities of light of 2 measurement items. This embodiment enables setting of an evaluation criterion on the scattergram. Preferably: the evaluation criterion is set based on a certain gate (gate). More preferably: the gate (gate) is set by the user. This embodiment makes it possible to set a rating standard for a certain gate (gate).
Preferably: in the accuracy control method, the evaluation criterion includes an upper limit value and a lower limit value of the intensity of light or the size of the particle. With this embodiment, an evaluation criterion can be set based on the intensity of light or the size of particles.
Preferably: in the precision management method, the evaluation criterion is set based on statistical information. With this embodiment, evaluation criteria can be set based on various statistical information.
Preferably: in the precision management method, a histogram or a scatter diagram is displayed on the input interface. With this embodiment, the user can set the evaluation criterion while viewing the histogram or scatter diagram displayed on the input interface.
Preferably: in the precision control method, the light is fluorescent light and/or scattered light. In this embodiment, evaluation criteria can be set for fluorescence, scattered light, and the like.
Preferably: the precision management method was performed using a flow cytometer. This embodiment makes it possible to set an evaluation criterion in a flow cytometer, in particular a multicolor flow cytometer.
Preferably: in the output step of the quality control method, the result of the quality control is displayed every time a control sample for each quality control is measured. By the implementation, the accuracy management result can be monitored in real time.
Preferably: in the output step, the result of the quality control is a result of the quality control for each channel, and is displayed on a graph developed with a plurality of channels as axes. By the implementation, the precision management results of a plurality of channels can be displayed on 1 interface.
Preferably: in the output step, the result of the quality control is displayed in a time-series chart. With this embodiment, the change within one day and the change between days of the quality control result can be grasped at a glance.
Another embodiment of the present disclosure relates to a measurement device (1000), the measurement device (1000) including: the device comprises a measurement unit (200) for measuring a management sample for performing quality management, a display unit (17), and a processing unit (10) for displaying the quality management result of an inspection item on the display unit, wherein the processing unit (10) acquires information corresponding to the management sample, and displays a quality management setting interface or a quality management interface of the corresponding inspection item on the display unit based on the acquired information. According to the present embodiment, a quality control setting interface or a quality control interface can be displayed for each control sample.
Preferably: the information corresponding to the control sample is display mode information corresponding to the control sample, and the quality control setting interface or the quality control interface of the inspection item corresponding to the acquired display mode information is displayed on the display unit so as to be switchable with the quality control setting interface or the quality control interface corresponding to the other display mode information. In this embodiment, it is possible to display a quality control setting interface or a quality control interface for different control samples on 1 interface.
Preferably: the processing unit reads reagent information from a barcode attached to an inspection reagent container or a package, and displays a quality control setting interface or a quality control interface of an inspection item corresponding to the display mode information on the display unit. With this embodiment, reagent information can be easily acquired even if the user does not input the reagent information. The present invention is useful in the case where an in vitro diagnostic reagent is used as a detection reagent.
The processing unit acquires reagent information through input by an input unit or from a network, and displays a quality control setting interface or a quality control interface of an inspection item corresponding to the display mode information on the display unit. With this embodiment, reagent information can be input even when a reagent for investigation is used.
Preferably: the control sample is a control sample of an in vitro diagnostic reagent or a control sample prepared using a research reagent, and the display mode information includes information on whether the control sample is a control sample of the in vitro diagnostic reagent or a control sample prepared using a research reagent. This embodiment enables the precision management of a control sample for in vitro diagnostic reagents and a control sample prepared using a research reagent.
Preferably: when a control sample prepared using a reagent for investigation is used as the control sample, an interface in which an evaluation criterion is set is displayed, and when a control sample of a reagent for in vitro diagnosis is used as the control sample, an interface in which an evaluation criterion is set is displayed. With this embodiment, on 1 interface, the quality control interface when using the in vitro diagnostic reagent, and the quality control setting interface and the quality control interface when using the research reagent can be displayed on 1 interface.
Another embodiment of the present disclosure relates to a precision management method including the steps of: the method includes a step of acquiring information corresponding to a control sample, a step of displaying a quality control setting interface or a quality control interface for displaying an inspection item corresponding to the control sample, a step of measuring the control sample for quality control, and a step of outputting a quality control result of the control sample measured in the measuring step. According to the present embodiment, a quality control setting interface or a quality control interface can be displayed in accordance with a control sample.
Preferably: in the quality control method, the information corresponding to the control sample is display mode information corresponding to the control sample, and the quality control setting interface or the quality control interface of the inspection item corresponding to the acquired display mode information is displayed on the display unit so as to be switchable with the quality control setting interface or the quality control interface corresponding to the other display mode information. In this embodiment, it is possible to display a quality control setting interface or a quality control interface for different control samples on 1 interface.
Preferably: in the quality control method, reagent information is read from a barcode attached to a test reagent container or a package, and a quality control setting interface or a quality control interface of a test item corresponding to the display mode information is displayed on the display unit. With this embodiment, reagent information can be easily acquired even if the user does not input the reagent information. The present invention is useful in the case where an in vitro diagnostic reagent is used as a detection reagent.
Preferably: in the quality control method, reagent information is acquired by an input unit or from a network, and a quality control setting interface or a quality control interface of an inspection item corresponding to the display mode information is displayed on the display unit. With this embodiment, reagent information can be input even when a reagent for investigation is used.
Preferably: the control sample is a control sample of an in vitro diagnostic reagent or a control sample prepared using a research reagent, and the display mode information includes information on whether the control sample is a control sample of the in vitro diagnostic reagent or a control sample prepared using a research reagent. This embodiment enables the precision management of a control sample for in vitro diagnostic reagents and a control sample prepared using a research reagent.
Preferably: in the accuracy control method, when a control sample prepared by using a reagent for study is used as the control sample, an interface for setting an evaluation criterion is displayed, and when a control sample of a reagent for in vitro diagnosis is used as the control sample, an interface for setting an evaluation criterion is displayed. With this embodiment, on 1 interface, the quality control interface when using the in vitro diagnostic reagent, and the quality control setting interface and the quality control interface when using the research reagent can be displayed on 1 interface.
Effects of the invention
With this embodiment, even when the management sample is not provided by the provider of the management sample or the provider of the measurement device, the condition for performing the accuracy management can be easily set and the accuracy management can be performed.
Drawings
FIG. 1 is a schematic illustration of the present disclosure;
FIG. 2 is a schematic view of a measurement system;
fig. 3 is a diagram showing a configuration example of hardware of the control device;
fig. 4 is a diagram showing a configuration example of the measurement unit;
FIG. 5 is a diagram of a display example of a login interface;
FIG. 6 is a diagram of a display example of a main interface;
FIG. 7 is a flowchart illustration of device Quality Control (QC) setting processing;
FIG. 8 is a diagram of a display example of a precision management setting interface;
FIG. 9 is a diagram of a display example of a precision management setting interface;
FIG. 10 is a diagram of a display example of a precision management setting interface;
FIG. 11 is a diagram of a display example of a precision management setting interface;
FIG. 12 is a diagram of a display example of a precision management setting interface;
FIG. 13-1 is a diagram of a flow chart illustration of an inspection item (panel) registration process;
FIG. 13-2 is a diagram of a flow chart illustration of the check item (panel) registration process;
FIG. 13-3 are diagrams of a flow chart illustration of the check item (panel) registration process;
FIG. 14 is a diagram of a display example of a precision management setting interface;
FIG. 15 is a diagram of a display example of a precision management setting interface;
FIG. 16 is a diagram of a display example of a precision management setting interface;
FIG. 17 is a diagram of a display example of a precision management setting interface;
FIG. 18 is a diagram of a display example of a precision management setting interface;
FIG. 19 is a diagram of a display example of a precision management setting interface;
FIG. 20 is a diagram of a display example of a precision management setting interface;
FIG. 21 is a diagram of a display example of a precision management setting interface;
FIG. 22 is a diagram of a display example of a precision management setting interface;
FIG. 23 is a diagram of a display example of a precision management setting interface;
FIG. 24 is a diagram of a display example of a precision management setting interface;
FIG. 25 is a diagram of a display example of a precision management setting interface;
FIG. 26 is a diagram of a display example of a precision management setting interface;
FIG. 27 is a diagram of a display example of a precision management setting interface;
FIG. 28 is a diagram of a display example of a precision management setting interface;
FIG. 29 is a diagram of a display example of a precision management setting interface;
FIG. 30-1 is a flow chart illustration of a baseline setting;
FIG. 30-2 is a flow chart illustration of a baseline setting;
FIG. 31 is a diagram of a display example of a precision management setting interface;
FIG. 32 is a diagram of a display example of a precision management setting interface;
FIG. 33 is a diagram of a display example of a precision management setting interface;
FIG. 34 is a flowchart illustration of daily Quality Control (QC);
FIG. 35 is a diagram of a display example of a precision management interface;
FIG. 36 is a diagram of a display example of a precision management interface;
FIG. 37 is a diagram of a display example of a precision management interface;
FIG. 38 is a diagram of a display example of a precision management interface;
FIG. 39 is a diagram of a display example of a precision management interface;
FIG. 40 is a diagram of a display example of a precision management interface;
FIG. 41 is a diagram of a display example of a precision management interface;
FIG. 42 is a diagram of a display example of a precision management interface;
FIG. 43 is a diagram of a display example of a precision management interface;
FIG. 44 is a diagram of a display example of a precision management interface;
FIG. 45 is a diagram of a display example of a precision management interface;
FIG. 46 is a diagram of a display example of a precision management interface;
FIG. 47 is a diagram of a display example of a precision management interface;
FIG. 48 is an explanatory flowchart of the measurement processing.
Detailed Description
Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In the following description and the drawings, the same reference numerals are used for the same or similar components, and the description thereof will be omitted.
[ summary of the present disclosure ]
An outline of the present disclosure will be described with reference to fig. 1. In the following description, the particle analyzer 1000 is used as the measurement device 1000 by way of example, but the measurement device 1000 is not limited to a measurement device that analyzes particles. Examples of the measuring apparatus include a nucleic acid amplification apparatus, a nucleic acid sequence analysis apparatus, an immunoassay apparatus, a biochemical measuring apparatus, a coagulation measuring apparatus, and a urine test apparatus. Fig. 2 shows an example of the structure of the particle analyzer 1000. One aspect of the present disclosure relates to assisting in the accuracy control in the particle analyzer 1000. Another aspect relates to accuracy control in the particle analyzer 1000. More preferably, the present invention relates to an inspection item not provided by a provider of measurement conditions of a control sample for controlling the accuracy of particle measurement in the particle analyzer 1000, and assists the accuracy control. More preferably: an evaluation criterion for quality control corresponding to the inspection item is generated in a file format that can be derived in the process of quality control in the particle analyzer 1000, and is stored in the auxiliary storage unit 13. The setting is received before the analysis of the measurement sample or at a certain time period when the measurement sample is analyzed.
In order to start up the particle analyzer 1000, the user accesses the control unit 100 of the particle analyzer 1000, and then the start-up processing of the particle analyzer 1000 is started (step S1). After the start-up processing is completed, the processing unit 10 of the control unit 100 starts the accuracy control of the measurement unit 200 of the particle analyzer 1000.
For example, the accuracy management of the measurement unit 200 includes accuracy management of the hardware itself of the measurement unit 200 (also referred to as device accuracy management or device QC) regardless of the inspection items, and accuracy management according to the inspection items (inspection item accuracy management) for monitoring the degradation of the measurement reagent and the like. As shown in fig. 1, after the user performs the operation of starting the particle analyzer 1000, the processing unit 10 performs the start-up process of the particle analyzer 1000 (step S1), and the processing unit 10 performs step S2 for performing device Quality Control (QC) of the measurement unit 200. Next, the processing unit 10 performs precision management of the inspection items. In order to perform quality control according to an inspection item (also referred to as a panel), an evaluation criterion for quality control according to the inspection item is required. For the inspection items for which the evaluation criteria have been set, the existing evaluation criteria are used. For the new inspection item, the processing unit 10 receives the setting of the evaluation criterion for performing the quality control corresponding to the inspection item (from step S3 to step S6). Alternatively, even when the evaluation criterion is set, for example, when the lot of quality control samples is changed, the processing unit 10 needs to perform the processing for setting the evaluation criterion. When setting the evaluation criterion of a new inspection item, the processing unit 10 receives registration of the inspection item (panel) by the user (step S3). Next, registration of a quality control file (QC file) concerning the registered inspection item (panel) is accepted (step S4) and setting of a baseline using a control sample for the registered Quality Control (QC) file is accepted (step S5). When the registered evaluation reference is to be updated, step S4 and step S5 are performed. The processing unit 10 creates a report on the set evaluation criterion as necessary (step S6). In step S7, the processing unit 10 performs accuracy control on each inspection item before each day of measurement using the set evaluation criterion. This quality control is also called daily Quality Control (QC). The result of the daily Quality Control (QC) may also be output as a report (step S8). After the daily Quality Control (QC) is performed, that is, after step S7 or after step S8, step S9 of measuring a measurement sample prepared from a sample may be included. The measurement result of the measurement sample may be output as a report (step S10).
The interfaces necessary in steps S3 to S6 for accepting the setting of the evaluation criterion for quality control according to the inspection items may be collectively referred to as a quality control setting interface.
In the present disclosure, the user is assumed to be an operator of the assay device. The operator includes, for example, a clinical laboratory technician, a researcher, a technician, an experiment assistant, a student, a manager of the measurement system, and the like. The user who sets the evaluation criterion described later preferably has a skill as a measurement device manager, for example. Examples of the skill of the administrator include those skilled in the measurement field, such as the length of the examination room, the chief and chief, the manager, and the measurement system administrator. The daily Quality Control (QC) described later can be performed by a person who does not have the skill as a manager.
[ particle analysis System ]
First, particle analysis of the quality control object in the present disclosure will be described.
Particle analysis is the analysis of particles. Preferably, the particles emit 1 or 2 or more kinds of light when irradiated with a certain light. The light emitted from the particles when irradiated with the predetermined light is collectively referred to as light from the particles. The light from the particles includes scattered light, fluorescence, and the like. The light from the particles may have any wavelength, but light having a peak wavelength in the range of 350nm to 850nm is preferable. More specifically, the light from the particles is preferably fluorescence. The light from the particles may be light emitted from a substance contained in the particles. Alternatively, the light from the particles may be labeled with a luminescent material such as a fluorescent material, and the light emitted from the luminescent material may be detected as the light from the particles. Further, it is preferable that the peak wavelength of the light from the particle is different for each measurement item.
The particles can be artificial particles such as magnetic beads, plastic beads and the like. The particles may be biological components such as tubes, or particles such as microorganisms, animal cells, and plant cells.
The particles are detected by the detection reagent. Preferably, the particles are detected by binding a fluorescent dye contained in the detection reagent to target molecules present in the particles.
The target molecule is not particularly limited as long as it is a substance present in the particle. Preferably: the particle is a cell and the target molecule may be a molecule present on, in, or within the cell membrane. The target molecule may also be the organelle itself (nucleus, nuclear membrane, nucleolus, mitochondria, endoplasmic reticulum, golgi apparatus, lysosomes, cell membrane, cytoplasm, etc.). The target molecule may be a molecule obtained by gene transfer or the like, for example. The target molecule is preferably at least one selected from the group consisting of an antigen and a nucleic acid.
The reagent for detecting the target molecule, which includes an antibody to which a fluorescent dye is bound, a nucleic acid to which a fluorescent dye is bound, a dye that emits a fluorescent signal, or the like, is referred to as a detection reagent. The detection reagent can be prepared by appropriately combining a plurality of detection reagents according to the detection items (target molecules) included in the test request. Preferably: when the target molecule is an antigen and is detected, an antibody for detecting the antigen is referred to as a detection antibody.
When the particles are derived from a living body, the sample is not particularly limited as long as it is a cell, tissue, body fluid containing cells, or the like taken from an individual. Prior to measurement, a cell sample obtained by diluting or fixing the sample or cells derived from the sample is mixed with a detection reagent to prepare a measurement sample (suspension of cells bound to a fluorescent dye) that can be measured in the particle analyzer 1000. The sample is preferably the distal blood, bone marrow, urine, or the like. For example, in multicolor flow cytometry, 1 or more, preferably several detection items contained in an examination item are generally analyzed in 1 cell sample by dividing the examination item into 1 to several tests (also referred to as detection). A group of 1 or more, preferably several detection items included in an inspection item is also called an inspection item (panel). The set of several test items determined in 1 test is also referred to as assay item (subset panel). Therefore, the test items include measurement items (subset panels) including 1 or more, preferably a plurality of detection items, and the test items (panels) include 1 or more, preferably a plurality of measurement items (subset panels). For example, when the test items (panel) include 20 test items, the test items are generally divided into 4 to 10 measurement items (subset panel) and measured.
In the present disclosure, particle analysis is performed by the particle analysis apparatus 1000. As shown in fig. 2, the particle analyzer 1000 includes, for example, a measurement unit 200 for performing particle analysis and a control unit 100 for controlling analysis in the measurement unit 200. The measurement unit 200 and the control unit 100 may be connected by a network wire or wirelessly, and the measurement unit 200 and the control unit 100 may be integrated. The particle analysis apparatus 1000 and the client terminal 300 may be connected to each other by wire or wirelessly via the network 99, thereby constituting a particle analysis system 5000.
The control unit 100 is constituted by, for example, a general-purpose computer, and generates the accuracy management data in a file format that can be derived in a process for the accuracy management of the particle analyzer, based on a flow shown in a flowchart to be described later, by setting the measurement conditions for measuring the accuracy management sample corresponding to the detection reagent for a combination of detection reagents for detecting particles whose measurement conditions for managing the accuracy of the particle analysis in the particle analyzer are not provided by a provider. The user mixes a detection reagent with the particle sample to prepare a measurement sample 29. The prepared measurement sample 29 is stored in the sample container 28, and placed in the measurement cell 200 to analyze particles.
Here, the control unit 100 controls the particle analysis in the particle analysis device 1000 and generates data including the management conditions for the quality management based on the measurement data of the management sample as an example, but data including the evaluation criteria for the quality management may be generated by a general-purpose computer different from the control unit 100 and transmitted to the control unit 100.
[ hardware configuration of control device ]
Fig. 3 illustrates an example of the hardware configuration of the control unit 100. The control unit 100 includes a processing unit 10. The control unit 100 may further include an input unit 16 and an output unit 17.
The control unit 100 includes: a processing unit 10 for performing data processing described later, that is, a cpu (central processing unit), a memory 12 serving as a work area for data processing, an auxiliary storage unit 13 for storing programs and processing data described later, a bus 14 for transferring data between the units, and an interface unit 15 (hereinafter, referred to as "I/F unit") for performing input/output of data and communication with an external device. An interface unit for performing communication among the interface units 15 is a communication unit 151. The input unit 16 and the output unit 17 are connected to the processing unit 10. In the present disclosure, the memory and the auxiliary storage unit 13 are collectively referred to as a storage unit. The input unit 16 and the output unit 17 (a display unit, a printer, or the like) can be integrated as a touch panel type input display device by way of example. The input unit 16 may be connected to a reading device such as a barcode reader, together with a keyboard and a mouse. The reading device can read, for example, a barcode or the like attached to a package of the detection reagent, in which information or the like of the detection reagent is registered.
In order to perform the steps of the auxiliary accuracy management described below, the control unit 100 stores the program according to the present disclosure in the auxiliary storage unit 13 in advance in an execution format (for example, generated by a compiler from a programming language conversion) and the processing unit 10 performs processing using the program stored in the auxiliary storage unit 13.
The processing unit 10 temporarily stores necessary data (intermediate data during processing, etc.) as a work area in the memory 12, and appropriately stores data stored for a long time such as an operation result in the auxiliary storage unit 13.
[ Structure of particle analyzing apparatus ]
The measurement unit 200 includes a suction unit 21, a fluid circuit 22, and a measurement unit 23. The measurement unit 200 aspirates the measurement sample 29 stored in the sample container 28 by the aspiration unit 21, fluidly conveys the aspirated measurement sample 29 by the fluid circuit 22, and measures the conveyed measurement sample 29 by the measurement unit 23.
In the present embodiment, the control unit 100 also performs the control operation of the measurement unit 200. That is, the optical information measured by the measuring section 23 is transmitted to the control section 100, and the control section 100 performs analysis corresponding to the number of particles and each antigen based on the optical information transmitted from the measuring section 23. The control unit 100 stores in advance a computer program defining a processing flow for controlling the measurement unit 200 and a processing flow for measuring the measurement value transmitted from the measurement unit 23 in the auxiliary storage unit 13 described later. The control unit 100 controls the measurement unit 200 by executing a computer program by the processing unit 10 described later.
The suction unit 21 is, for example, a nozzle capable of sucking and discharging a measurement sample or the like. The fluid circuit 22 is a flow path for a fluid, which is carried, for example, by a syringe pump. The particle analysis system 1000 is, for example, a flow cytometer. Preferably a multi-color flow cytometer. Flow cytometry optically measures a sample by flow cytometry. Hereinafter, a case will be described as an example in which the particle is a cell and the detection reagent contains an antibody that detects a target molecule present in the cell.
The number of light-receiving elements (e.g., photomultiplier tubes) for fluorescence detection provided in the measurement unit 23 is determined according to the number of fluorescent dyes that can be processed by the measurement unit 200. For example, if the measurement unit 200 can process 10 fluorescent dyes in 1 test, the measurement unit 200 includes 10 total light receiving elements for fluorescence measurement in the measurement unit 23. Hereinafter, an optical system of a flow cytometer will be described with reference to fig. 12, taking a case where a plurality of fluorescence are measured simultaneously as an example. The dotted line indicated by reference numeral 77 in fig. 4 means a diagram in which the light receiving element that is originally present is omitted.
Fig. 4 shows an example of an optical system of the flow cytometer as an example of the measurement unit 23. The flow cytometer includes: a cell 27 containing a cell-containing liquid containing cells in a measurement sample, light sources 201 and 224 for irradiating the cells passing through the cell 27 with light, and light receiving elements 200A to 200F for detecting optical information of the light from the cells and outputting detection signals converted into electric signals. The actual number of light sources is not limited to 2, but 3, but the light sources 201 and 224 are exemplified for the convenience of description. In the following description relating to the flow cytometer of fig. 3, a case where the measurement sample 29 is a mixture of blood and an antibody reagent will be described as an example.
Preferably, the cells emit 1 or 2 or more kinds of light when irradiated with a certain light. The light emitted from the cell when irradiated with a certain light is collectively referred to as light from the cell. The light from the cell includes scattered light, fluorescence, and the like. The light from the cell may have any wavelength, but is preferably light having a peak wavelength in the range of 350nm to 850 nm. More specifically, it is preferable that the light from the cell is fluorescence. The light from the cell may be light emitted from a substance contained in the cell itself. Alternatively, the light from the cell may be detected by the cell as light from the cell, the light being emitted by a fluorescent dye contained in the detection reagent in the analysis of the cell. The light from the cell preferably has a peak wavelength different for each antigen. In embodiment 1, the fluorescence from the cells is derived from a fluorescent dye labeled with each antibody contained in the detection reagent.
The cell-containing solution is a solution containing a measurement sample aspirated from the sample into the flow cytometer, and if necessary, a diluent. The optical information is information contained in 1 or 2 or more kinds of optical wavelength spectra emitted from the cells. The optical wavelength spectrum includes the individual optical wavelengths, optical wavelength regions, and intensities of the individual optical wavelengths or optical wavelength regions included in the optical wavelength spectrum. Each light wavelength and wavelength region can be specified by which of 1 type or 2 or more types of light receiving elements described later receives light. The intensity of each light wavelength or light wavelength region can be specified by an electric signal output from the light receiving element that receives the light.
Hereinafter, the case where light from the cell is scattered light or fluorescence will be specifically described as an example. Light emitted from the light source 201 passes through the collimator lens 202, the dichroic mirror 203, and the condenser lens 204 and is irradiated to the chamber 27. The forward scattered light of the light from the cell passing through the cell 27 is collected by the condenser 205, and enters the light receiving element 200A through the beam stopper 206, the orifice plate 207, and the band pass filter 208.
On the other hand, the side scattered light and the side fluorescence of the light from the cell passing through the chamber 27 are collected by the condenser 209. The side scattered light enters the light receiving element 200B through the dichroic mirror 210, the dichroic mirror 211, the dichroic mirror 212, the aperture plate 213, and the band pass filter 214. The lateral fluorescence transmission dichroic mirrors 210 and 211 having wavelengths of 520nm to 542nm are reflected by the dichroic mirror 212, pass through the aperture plate 215 and the band-pass filter 216, and enter the light receiving element 200C. The lateral fluorescence transmission dichroic mirror 210 having a wavelength of 570nm to 620nm is reflected by the dichroic mirror 211, passes through the aperture plate 217 and the band-pass filter 218, and enters the light receiving element 200D. The lateral fluorescence having a wavelength of 670nm to 800nm is reflected by the dichroic mirror 210, passes through the dichroic mirror 219, passes through the aperture plate 220, passes through the band-pass filter 221, and enters the light receiving element 200E.
Light emitted from the light source 224 is irradiated to the chamber 27 through the collimator lens 225, the dichroic mirror 203, and the condenser lens 204. Lateral fluorescence of light from the cells passing through the chamber 27 is collected by the condenser lens 209. The lateral fluorescence having a wavelength of 662.5nm or more and 687.5nm or less is reflected by the dichroic mirror 210 and the dichroic mirror 219, and then enters the light receiving element 200F through the aperture plate 222 and the band-pass filter 223.
In the example shown in FIG. 4, the light source 201 uses a laser diode having a wavelength of 488nm, and the light source 224 uses a laser diode having a wavelength of 642 nm. Chamber 27 uses a sheath flow cell. The light receiving element 200A that receives the forward scattered light uses a photodiode, and the light receiving element 200B that receives the side scattered light uses an Avalanche Photodiode (APD). The light receiving elements 200C to 200F that receive the lateral fluorescence use photomultiplier tubes (PMT).
Thus, in the flow cytometer shown in fig. 4, for convenience of explanation, the number of light receiving elements 200C to 200F that receive the lateral fluorescence is 4. But in practice there are 10. Therefore, the flow cytometer shown in this example includes 4 light-receiving elements for fluorescence detection, and can simultaneously measure fluorescence of 4 colors in 1 test. However, in practice, the flow cytometer includes 10 light-receiving elements for fluorescence detection, and can simultaneously measure 10 colors of fluorescence in 1 test.
The detection signals output from the light receiving elements 200A to 200F are amplified by an amplification circuit (not shown) and are a/D converted into digital signals by an a/D converter (not shown). In the present embodiment, the detection signal converted into a digital signal is transmitted to the control unit 100, and the cell is analyzed. The amplification circuit is a known amplification circuit composed of, for example, an operational amplifier.
The number of the light sources may be 1 or 2 or more. Preferably: the flow cytometer is equipped with at least 3 light sources. The light source is selected according to the wavelength region of light from the cell. When the number of light sources is 2 or more, it is preferable that the light sources emit light having different peak wavelengths.
The number of photodiodes, dichroic mirrors, and bandpass filters can be changed according to the number of peak wavelengths of light from the cell. The types of the photodiode, the dichroic mirror, and the band-pass filter can be selected according to the peak wavelength, the wavelength range, and the intensity of the light from the cell.
The control unit 100 sends information on detection sensitivity when the measurement unit 23 detects scattered light or fluorescence, information on fluorescence correction according to a combination of detected fluorescence, and information on gating for selecting a distribution region of the detected cell to the measurement unit 23, and controls the measurement unit 23 so that appropriate optical information can be acquired for each antigen based on the information.
[ outline of operation of control Unit ]
In the control unit 100, the processing unit 10 acquires, for example, a request for an examination required by a doctor to determine whether or not a patient has a certain disease (e.g., leukemia). The user prepares the measurement sample 29 for each of the plurality of measurement items corresponding to the received examination request and places the measurement sample in the measurement unit 200. Then, based on the input of the measurement start instruction from the user, the measurement unit 200 performs the measurement of each target molecule according to the process flow of the cell analysis described later.
[ client terminal ]
Further, the particle analyzer 1000 and the client terminal 300 may be connected to each other through a network 99. For example, a doctor transmits an examination request instructed from the requester terminal 300 to the particle analyzer 1000 via a network. The client terminal 300 is constituted by, for example, a general-purpose computer having a processing unit 10 and a memory. The sample of the examination object is additionally handed to the user. The deleter terminal 300 transmits the input inspection request to the control unit 100. Further, the particle analysis apparatus 1000 may transmit the measurement result to the client terminal 300.
[ method for assisting precision management and method for precision management ]
The present disclosure relates to assisting in the accuracy control of cell analysis performed in the particle analysis apparatus 1000. First, an outline of the quality control will be described.
(overview of precision management and Effect of assistance method)
The quality control includes internal quality control for controlling the analysis quality in each inspection room and external quality control for controlling the analysis quality between independent inspection rooms. The present disclosure relates to internal precision management. Reference to "quality management" or "QC" in this disclosure only means internal quality management.
The accuracy of particle analysis is managed to monitor the reproducibility and variation of the analysis. The quality control includes quality control (device quality control or device QC) relating to the analytical performance of the measurement unit 200 itself and quality control (test item quality control) of test items reflecting the quality of the detection reagent and the preparation method of the measurement sample. In the present disclosure, the precision management is preferably inspection item precision management.
Hereinafter, a method for assisting accuracy control will be described by taking a cell analysis using a flow cytometer as the measurement unit 200 and a detection antibody as a detection reagent as an example.
In general, when device Quality Control (QC) is performed, a control sample (device control sample) for device quality control, including fluorescent beads or the like corresponding to the fluorescence wavelength measured by the measurement unit 200, is used. Specifically, when the measurement unit 200 is started, it is preferable to start measurement of such a device management sample and confirm that the detection system of the measurement unit 200 is operating normally. As a result of the accuracy management of the apparatus, it is preferable to store the history in the auxiliary storage unit 13, including the contents thereof, every time the accuracy management is performed and every time an abnormality occurs.
Then, the precision management of the inspection items is performed according to the inspection items. General inspection items are described in an inspection order or the like, and correspond to the type of particles to be inspected, and the like. When the examination items are examined, a plurality of target molecules corresponding to the types of particles are measured as detection items in the measurement unit 200. For example, the examination items (cell types) are CD 4-positive T cells, and the detection items (types of target molecules) satisfying the request are CD3 and CD4, which are surface antigens of T cells. The inspection item accuracy management is preferably performed for each inspection item and for all detection items included in each inspection item. Therefore, it is preferable to perform the precision control of the examination item using a cell of the same type as or similar to the cell of the examination item and using a control sample (examination item control sample) prepared using the same detection reagent as that used in the preparation of the measurement sample from the sample so as to satisfy the examination request. The precision control of the test items is preferably performed before the measurement of the measurement sample. As a result of the quality control of the inspection items, it is preferable that the auxiliary storage unit 13 stores a record including the contents thereof every time the quality control is performed and every time an abnormality occurs.
The above-mentioned device quality control and inspection item quality control is sometimes called daily Quality Control (QC) because it is performed at least 1 time, for example, on the measurement day when the device is started up or before the measurement of the measurement sample.
In the present disclosure, the device management sample and the inspection item management sample are collectively referred to as a management sample in some cases. When the device management sample is obtained from a provider of the management sample or a provider of the particle analyzer 1000, information such as measurement conditions of the device management sample is generally provided in the particle analyzer 1000. On the other hand, regarding the inspection item management sample, even if it is assumed that the inspection item management sample is obtained from a provider, information on the measurement conditions of the inspection item management sample is not provided in many cases. In particular, when the particle analyzer 1000 is a multicolor flow cytometer, information on the measurement conditions of the test item control sample is not provided.
Further, the types of management samples provided by the management sample provider and the particle analyzer provider are limited, and it is not always possible to obtain a commercialized inspection item management sample in response to an inspection request. In this case, it is necessary to prepare a control sample, particularly an inspection item control sample, in each inspection room.
Therefore, the user needs to set, in each examination room, in particular, measurement conditions for the examination item management sample and/or setting of evaluation criteria for performing accuracy management.
Conventionally, the control unit 100 of the particle analyzer 1000 manages the device accuracy management. On the other hand, the result of the quality control of the sample using the inspection items is not always managed by the system of the control particle analyzer 1000. Therefore, each inspection room needs to manage the result of the accuracy management of the inspection items by a system different from the system for controlling the particle analyzer 1000.
In the present disclosure, the condition setting for managing the accuracy control of the sample using the inspection items and the management of the result of the accuracy control measured based on the set conditions can be performed in the control unit 100 that controls the particle analyzer 1000. In other words, an evaluation criterion used for quality control using an inspection item management sample is input to the control unit 100, and the result of the quality control performed is displayed on the application interface of the particle analyzer 1000 based on the input evaluation criterion.
(method of assisting precision management)
In step S1 of fig. 1, when the user inputs an instruction to perform the activation process to the control unit 100 (for example, activates application software for performing particle analysis), the processing unit 10 displays the login interface L shown in fig. 5. The processing unit 10 receives input processing of, for example, a user ID and a password from the login interface, and displays the main interface B shown in fig. 6 on the output unit (display unit) 17.
First, the main interface B shown in fig. 6 and the respective processes for assisting the quality control will be described. Each interface is a user interface that accepts user input to assist with accuracy management. The "input area" used in the following description is an area in which necessary information is input by a user performing character input from an input unit. The "icon" is a selection area in which an interface for performing processing that the user desires to operate is displayed by the user selecting the area. The user can operate the input unit 16 and select an icon. The "pull-down list" is a list in which, when the user selects the area using a mouse or a touch panel, the items stored in the memory 12, the auxiliary storage unit 13, or the like are displayed in a list form, and the user can select each item displayed in the list.
Seed boundary
Fig. 6 illustrates a main interface B for performing an operation for controlling the particle analyzer 1000. The main interface B is an interface that is displayed after the control unit 100 is started and the application controlling the particle analyzer 1000 is started. The main interface B includes a main operation area B1, a work list area B2, a particle analysis condition setting area B3, an analysis state display area BA, and an analysis operation area B6.
The Main operation area B1 displays a Main (Main) icon B11 for displaying the Main operation area, a Quality Control (QC) icon B12 for displaying the quality control area, a setting icon B13 for causing the particle analysis condition setting area B3 to display, a maintenance icon B14 for causing the maintenance area to display, and an exit icon B15 when the user exits from the Main interface. The computer program for assisting quality management in the present disclosure can be accessed from a quality management (QC) icon B12.
The work list area B2 is displayed in a selectable manner: a work list tab B22 showing a list of measurement samples to be measured, and a test item management (panel master) tab B23 for setting test items to be measured for each measurement sample.
In the particle analysis condition setting region B3, there are displayed such that: setting label B33 for measurement conditions and stop label B34 for analysis completion operation are set.
In the analysis state display area BA, the following are displayed so as to be selectable: a home label BA1 for displaying light received from the measurement sample in real time or as a recorded image, and labels BA2 to BA5 for performing other operations. In a home page (home) tab BA1, a selection is made: a chart (plot) label BA10 for plotting a scattergram of light received from the measurement sample, a report label BA5 for displaying the result, and the like.
In the analysis operation area B6, there are displayed: a measurement device state display region B60, a measurement device name display region B61, a measurement start icon B62, a measurement stop icon B63, a measurement cancel icon B64, regions B66 to 68 in which the number of measurement particles and the measurement time are displayed, an icon B70 for displaying the remaining amount of reagent, an icon B71 for displaying the waste liquid state, an icon B72 indicating the printer state, an error display icon B73, a measurement sample information input region B74, a message display region B75, a measurement mode display region B76, and a user information display region B77 for operating the measurement unit 200.
The operation interface described below including the main interface is displayed by the processing unit 10 executing application software or the like stored in the auxiliary storage unit 13, for example.
Seed and plant precision management (QC) setup process
The processing unit 10 performs device Quality Control (QC) setting processing in step S2 shown in fig. 1. An example of the device Quality Control (QC) setting process will be described below. In order to set a management condition for managing measurement data of a sample by a user, for example, the processing unit 10 receives a selection of a Quality Control (QC) icon B12 of the main interface B shown in fig. 6 for controlling the operation of the particle analyzer 1000 by the user (step S101 shown in fig. 7), and displays a Quality Control (QC) file list region BQC0 and a measurement item (subset panel) list display region BQC3 instead of the work list region B2 as shown in fig. 8. A quality management (QC) file operation region BQC1 for operating a quality management (QC) file, and a list display region BQC2 for displaying a list of quality management (QC) files are displayed in the quality management (QC) file region BQC 0. A Quality Control (QC) icon X1 for performing Quality Control (QC) files in the list display area BQC2 selected, for example, with a cursor, a setting icon X2 for performing Quality Control (QC) file setting, a device Quality Control (QC) file registration icon X3 for registering new Quality Control (QC) files, a measurement item (subset panel) selection icon X4, and a deletion icon X5 are displayed in the Quality Control (QC) file operation area BQC 1. The Quality Control (QC) file corresponds to each inspection item (panel). A list BQC4 is displayed in the measurement item (subset panel) file region BQC3, and this list BQC4 displays measurement items (subset panels) contained in each check item (panel) selected by a cursor or the like in the list display region BQC 2.
In step S101 shown in fig. 7, as shown in fig. 8, the processing unit 10 displays a region BQC5 indicating the measurement result of the control sample instead of the particle analysis condition setting region B3. In the region BQC5, in a manner enabling selection: a radar icon label BQC6 that displays measurement results for each channel, and an L-J chart label BQC7 that represents measurement results for each channel in time series.
In step S102 shown in fig. 7, the processing unit 10 receives selection of the icon X3 by the user, and displays a device Quality Control (QC) file dialog box for setting the management conditions for the measurement data of the new management sample shown in fig. 9 (step S103).
A Quality Control (QC) file registration dialog box X3D is displayed. In the device Quality Control (QC) file registration dialog X3D, for example, there are displayed: a drop-down list area X3D1 indicating the name of an inspection item (panel) which is a Quality Control (QC) file of the device, a drop-down list area X3D2 selecting the name of a device management sample, an area X3D4 into which the lot number of the device management sample is input, an area X3D5 inputting the lifetime of the device management sample, a confirm (OK) icon X3DE confirming the input and advancing to the subsequent step, and a cancel icon X3DC suspending the setting are selected.
In step S104, the processing unit 10 accepts selection of the pull-down list area X3D1 by the user, for example. The processing unit 10 receives the lot number of the device management sample input by the user to the area X3D4 and/or the lifetime of the device management sample input to the area X3D5 as necessary. Next, in step S105, in response to the user' S selection of the OK icon X3DE, the processing unit 10 stores each input content input to the device quality management (QC) file registration dialog X3D, and closes the device quality management (QC) file registration dialog X3D. The interface display returns to the main interface B of the display quality management (QC) file BQC0 shown in fig. 10 (step S106).
In step S107, the processing section 10 selects a quality management (QC) file that should be set in accordance with the user 'S specification of the quality management (QC) file listed in the device quality management (QC) file list BQC2 (step S107), and accepts an instruction for quality management (QC) file setting in accordance with the user' S selection of the setting icon X2 to set a baseline (step S108).
Next, the processing unit 10 displays a baseline dialog X2D (fig. 11) for setting a baseline (step S109). Displayed in the baseline dialog box X2D: a start icon X2D1 for starting measurement, a measurement item (subset panel) list display area X2D2, a light-receiving element status display area X2D4, a confirm (OK) icon X2DE for confirming an input and advancing to a subsequent step, and a cancel icon X2DC for stopping setting. The measurement item (subset panel) list display region X2D2 displays the measurement item (subset panel) list X2D 3. In addition, in the region indicated by the light-receiving element status indication region X2D4, the voltage and the variance of each light-receiving element (PMT) are indicated for each channel (type of received light) (RubustCoefficientValue: rCV). The PMT voltage rCV includes a region for displaying a Target Value (Target) and a region for displaying an actual measurement Value (Value). The light receiving element for precision control includes an element for receiving fluorescence, an element for receiving forward scattered light (FSC), and an element for receiving side scattered light (SSC).
After step S109 or before step S109, the user prepares the device management sample and places it in the aspirating unit 21 of the particle analyzer 1000.
In step S110, the processing unit 10 receives the selection of the start icon X2D1 by the user, and starts measurement of the device management sample. As shown in fig. 12, the processing unit 10 displays the PMT voltages rCV of the respective channels of the control sample being measured (step S111). The processing unit 10 stores in advance the PMT voltages and the target values of rCV in the storage unit when the measurement unit 200 measures the control sample. Therefore, when the device management sample is measured, the voltage applied to the light receiving element is automatically adjusted so that the actual measurement value of the PMT voltage approaches the target value, preferably, to the order of ± 300V of each target value (step S112).
The processing unit 10 automatically ends the measurement after the PMT voltages of the light receiving elements are adjusted by all the channels. After the measurement is completed, the determination icon X2DE can be selected. The processing unit 10 receives a selection of the selectable identification icon X2DE by the user (step S113), and stores the PMT voltage value of each channel and rCV calculated by the processing unit 10 as a set value for the inspection item precision management (QCpanel) (step S114). The processing unit 10 ends the device Quality Control (QC) setting process, closes the baseline dialog box X2D, and displays the main screen B for displaying the work list region B2 (step S115).
(registration processing of examination item (panel))
In order to assist the quality control using the control samples prepared in the respective test chambers, the present disclosure performs the setting process of Quality Control (QC) of the test items by operating the interfaces illustrated in fig. 14 to 22 and 24 from step S3 to step S6 of fig. 1. That is, the setting process of the check item Quality Control (QC) can include a registration process step S3 of the check item (panel), a Quality Control (QC) file registration process (step S5), and a setting process of the baseline (step S6). The setting process of the inspection item Quality Control (QC) may further include a report creation process (step S7).
Registration of seeds, and seeds for seed and inspection item (panel) by setting management of seed and inspection item precision (QC)
An example of the inspection item Quality Control (QC) setting process will be described below. In the inspection item Quality Control (QC) setting process, first, the processing unit 10 receives registration of an inspection item (panel) by a user. The processing unit 10 accepts a user selection of an examination item management (panel master) tab B23 displayed in the work list area B2 of the main interface B shown in fig. 6 (fig. 13-1, step S301). The processing unit 10 displays an inspection item management (panel master) tab B23 (fig. 13-1, step S302). In the case where the check item management (panel master) tab B23 is displayed from the beginning, step S301 and step S302 may be skipped. As shown in fig. 6, at the check item management (panel master) tab B23, a check item (panel) list area B230 and a check item (panel) setting list B231 are displayed at the check item management (panel master) tab B23, wherein the check item (panel) list area B230 includes a check item (panel) registration icon B222 selected when setting of new check item quality management (QC) is started, a check item (panel) change icon B223 for changing already registered check item quality management (QC), a copy icon B225 for copying already registered check item quality management (QC), a delete icon B226 for deleting already registered check item quality management (QC), an import icon B228 for reading in already registered check item quality management (QC), an export icon B229 for starting writing check item quality management (QC), and the like. In addition, a measurement item (subset panel) list display area B232 is displayed in the lateral direction of the examination item (panel) list area B230. When the user selects 1 examination item (panel) set listed in the examination item (panel) setting list B231, a list of measurement items (subset panels) included in the examination item (panel) setting is displayed in the measurement item (subset panel) list display area B232. A duplication icon G8 for duplicating the measurement item (subset panel) setting and a removal icon for deleting the setting are displayed in the measurement item (subset panel) list display area B232.
In step S303 of fig. 13-1, the processing unit 10 accepts selection of the check item (panel) registration icon B222 in the check item (panel) list region B230 by the user, and displays the check item management (panel master) registration dialog G1D shown in fig. 14. In the check item management (panel master) registration dialog G1D, there are displayed: a check item (panel) name input region G1D1 for inputting a check item name or the like, a panel id input region G1D2 for inputting an identification number of the check item (panel), a comment input region G1D3 in which comments on the check item or the like can be input, a measurement item management (subset panel master) display region G1D4 that displays an input for displaying a list of measurement items included in the check item (panel), a determination icon G1DE selected when determining a check item management (panel master) registration dialog G1D, and a cancel icon G1DC selected when setting is to be suspended. In the measurement item management (subset panel master) region G1D4, there are shown: the measurement item (subset panel) list G1D41, a measurement item (subset panel) registration icon H1 for registering a new measurement item (subset panel), a measurement item (subset panel) update icon H2 to be selected when the setting of a registered measurement item (subset panel) is updated, a deletion icon H3 for deleting the setting of a measurement item (subset panel), and a duplication icon H4 for duplicating the setting of a measurement item (subset panel).
In step S305 of fig. 13-1, the processing unit 10 accepts an input from the user to each input region of the check item management (panel master) registration dialog G1D. In fig. 14, as an example, "6 CTBNK" is input to the examination item (panel) name input region G1D 1. For example, "1234" is input to the panel id input region G1D 2. Next, in step S306, the processing unit 10 accepts selection of the measurement item (subset panel) registration icon H1 by the user.
Next, in fig. 13-1 and step S307, the processing unit 10 displays a measurement item (subset panel) registration dialog H1D shown in fig. 15. In the measurement item (subset panel) registration dialog H1D, there are displayed: a measurement item (subset panel) name input region H1D1 for inputting a measurement item (subset panel) name and the like, a measurement item (subset panel) ID input region H1D2, a comment input region H1D3 for inputting comments as necessary, a detection reagent name input region H1D4 for inputting the name of a detection reagent, a detection reagent ID input region H1D5 for inputting the identification number of a detection reagent, a determination icon H1DE for determining input, and a cancel icon H1DC for suspending setting. In step S308 of fig. 13, the processing unit 10 receives an input from the user to each input region of the measurement item (subset panel) registration dialog H1D. Here, as an example, "CD 3/CD 4/CD 8/CD 16.", and "1234" are inputted to the measurement item (subset panel) name input region H1D1, and "1234" is inputted to the subset panel id input region H1D 2. Several measurement items (subset panel) can be registered.
After the user inputs the measurement item (subset panel) registration dialog H1D, the processing unit 10 accepts the user's selection of the identification icon H1DE, and closes the measurement item (subset panel) registration dialog H1D. Next, the processing unit 10 accepts the user' S selection of the identification icon G1DE in the check item management (panel master) registration dialog H1D, and closes the check item management (panel master) registration dialog H1D (fig. 13-1, step S310).
After closing the check item management (panel master) registration dialog G1D, the processing unit 10 displays the names of the newly registered check items (panels) in the check item management (panel master) tab B23 of the main interface B in the check item setting list B231 in the processing from step S301 to step S309 as shown in fig. 16. (here, "6 CTBNK" is displayed in the inspection item (panel) setting list B231, in addition to the name of the inspection item (panel), can display the date and time at which the inspection item (panel) was registered.
Next, the processing unit 10 selects an inspection item (panel) for newly registering inspection item Quality Control (QC) from among the inspection items (panels) displayed in the inspection item (panel) setting list B231, and the processing unit 10 receives the selection (fig. 13-2, step S311). For example, "6 CTBNK" is selected herein. When the user selects 1 inspection item (panel), the processing unit 10 displays the channel condition setting region B335 of the setting label B33 for setting the light receiving conditions such as the gain of each light receiving element in the particle analysis condition setting region B3 as shown in fig. 17, and receives the user' S input or selection of each region (fig. 13-2, step S312). In region B335, FSC represents forward scattered light and SSC represents side scattered light. The Name (Name) indicates an input area B334 in which the user can input information such as what light is detected by each light receiving element. The Gain (Gain/PMT) represents the amplification voltage of the light receiving element. The Threshold (Threshold) is typically set in terms of FSC, which is a critical value set for receiving light of a fixed intensity or above. Time indicates whether a Time axis is to be acquired, Logic indicates a Threshold (Threshold) theoretical acquisition condition, Height indicates whether a peak of fluorescence intensity is to be acquired, and Area indicates whether an Area value is to be acquired. For each light receiving element, input regions B336 and B337 for inputting values by the user are displayed in the Gain (Gain/PMT) and Threshold (Threshold) columns. The input to this region may be a value input by the user received by the processing unit 10, or the processing unit 10 may display the setting of the Gain (Gain/PMT) and Threshold (Threshold) for each light receiving element, stored in the storage unit in association with each light receiving element. The input setting is temporarily stored in the memory 12 when the tag is switched or when the check item (panel) is switched.
In the channel condition setting area B335, the user can change the display area by the scroll key SC. In the example shown in fig. 17, the number of light-receiving elements for receiving fluorescence can be set from FL1 to FL10, and can depend on the number of laser light sources mounted on the measurement unit 200.
By scrolling the channel condition setting region B335 downward, the processing unit 10 displays the flow rate setting region B341 illustrated in fig. 18 below the channel condition setting region B335, displays the setting region B351 of the laser beam to be used below the flow rate setting region B341, and accepts input or selection of each region by the user (fig. 13-2, step S313, and step S314). The flow rate setting region B341 is provided with a flow rate adjustment bar B342 capable of adjusting the flow rate of the flow cytometer in stages. The processing unit 10 receives the adjustment of the flow rate adjustment bar B342 by the user operation, and controls the flow rate of the liquid in the flow cell 27 of the measurement unit 200 via the I/F unit 15. In the laser light setting region B351, an icon B352 of the laser light which can be selected by the user is provided, and for example, when the user selects the icon B352 having a wavelength lower than the wavelength which is not used, the processing unit 10 changes the icon color to display the icon so as to indicate that the laser light is not selected, and the processing unit 10 transmits information that the icon is selected to the measurement unit 200 via the I/F unit 15. The following embodiments are also possible: when the user selects the icon B352 below the wavelength to be used, the processing unit 10 displays the icon with the color changed so as to indicate that the laser beam has been selected, and the processing unit 10 transmits information that the icon has been selected to the measurement unit 200 via the I/F unit 15.
Next, the processing unit 10 receives a selection of the stop (stop) tab B34 by the user. Next, the processing unit 10 displays the stop (stop) tab B34 illustrated in fig. 19, and accepts user input or selection of each area (fig. 13-2, step S315). Stop (stop) tag B34 includes: a Stop logic setting (Stop LogicSetting) area B361, an Event Count (Event Count) area B362, and a Time (Time) area B363 for accepting input of setting of a Stop condition. In the Stop Logic Setting (Stop Logic Setting) area B361, if a Stop condition Logic Setting icon B3611 is included and the Setting is set to "or", the Setting cannot be changed. The Event Count (Event Count) area B362 includes a pull-down list display area B3621 for setting a stop condition (Stopcondition) and an input area B3622 for stopping the measurement of the number of cells. The Time (Time) region B363 includes an input region B3631 for inputting Time settings for ending measurement at a fixed Time. An Event Count (Event Count) field B362 and a Time (Time) field B363 can select one of them. When the condition input by the user is satisfied, the processing unit 10 transmits a measurement stop instruction to the measurement unit 200 via the I/F unit 15.
The input setting is temporarily stored in the memory 12 when the tag is switched or the check item (panel) is switched, or automatically stored in the storage unit in the auxiliary storage unit 13 (fig. 13-2, step S316).
Next, the processing unit 10 accepts insertion of a new chart by the user. The processing unit 10 accepts input of a new chart input by the user to the chart (plot) tab of the home (home) tab BA1 displayed in the area BA of fig. 20. In addition, in a case where the home tab BA1 is not displayed, the user' S selection of the home tab BA1 is accepted before accepting the input of a new chart to be input to the chart (plot) tab (fig. 13-3, step S317). The home (home) tab BA1 includes a chart insertion area BA1A for insertion of drawing, and a chart display area BA1B for displaying a chart. The chart insertion area BA1A includes: a gate (gate) area BA1a1 area including an icon for inserting a gate (gate), an additional chart (Add Plot) area BA1a2 including an icon for adding a chart to the chart display area BA1B, an area BA1A3 for displaying a parent gate (ParentGate) for developing only particles in the gate (gate) set in the upper gate (gate) in the chart, and an Edit (Edit) area BA1a4 including a delete icon for deleting the chart. The processing unit 10 accepts selection of a certain icon displayed in the additional chart (AddPlot) area BA1a2 by the user, and additionally displays an empty chart corresponding to the selected icon in the chart display area BA1B (fig. 13-3, step S317).
Next, the processing unit 10 accepts the setting of the chart added in step S316 by the user. Specifically, upon receiving the selection of the view tab BA2 by the user, the view tab illustrated in fig. 21 is displayed (step S318). In view (view) tab BA2, show: a chart setting area BA2A for setting display of each chart, and a chart display area BA1B for displaying each chart. In the chart setting area BA2A, the chart setting area BA2A further includes a zoom (Scaling) area BA2a1 and a Histogram style (Histogram style) area BA2a 2. In the zoom (Scaling) area BA2a1, input areas for setting the X axis and the Y axis of each chart are displayed. With respect to the respective axes, there are included: a pull-down list for setting the light receiving elements displayed on the axes (X axis BA21, Y axis BA 211), a pull-down list for selecting the straight line display or the logarithmic display (X axis BA22, Y axis BA 212), an input area for inputting the minimum value of the axes (X axis BA23, Y axis BA 213), an input area for inputting the maximum value of the axes (X axis BA24, Y axis BA 214), and a pull-down list for displaying 1 parameter of double index (logistic) — Negative% (X axis BA25, Y axis BA 215). In the histogram style (histogram type) area BA2a2, an Auto Scaling (Auto Scaling) selection area BA221 for allowing the user to select whether or not to automatically set an axis, and an area BA222 for inputting a Max count, which is a display area of the Y axis of the selected histogram, are included in the chart setting area BA 2A. In the chart display area BA1B, a chart (plot) tab BA10 for displaying a chart and a report tab BA20 for generating a report are included.
In the graph (plot) label shown in fig. 21, the signal received by the measuring unit 200 is displayed as a 2-axis scattergram of combinations of different light receiving elements in 6 graphs of graphs 1 to 6, for example, but each graph can be displayed by the number of combinations of different light receiving elements. The graph is not limited to a scattergram, and the light receiving element may express the intensity of light and the number of particles by creating a histogram of the signal received by the measurement unit 200.
The user can select each chart by, for example, clicking on the displayed chart. Regarding the graph selected by the user, the processing unit 10 receives the setting of the axis set by Auto Scaling (Auto Scaling), which is a function of displaying the range of the maximum value and the minimum value of the measured particle for the graph being selected, or receives the contents of the selection or input of each region of the graph setting region BA2A by the user for each graph (fig. 13-3, step S319).
When the user completes setting all the charts, the processing unit 10 receives input of this information (fig. 13-3, step S320). When receiving the input of the information (Yes), the processing unit 10 temporarily stores the contents set for each graph in the memory 12 or automatically stores the contents in the auxiliary storage unit 13 in the storage unit when switching the label or switching the check item (panel) (step S321). When the input of this information has not been completed, the process returns to step S319 and accepts further selection and input of the chart by the user.
Next, the processing unit 10 sets a gate (gate) for the chart whose setting has been completed, which is stored in step S320. The processing unit 10 receives a user selection of a home tab BA1, and displays a chart insertion area BA1A (see the chart insertion area BA1A in fig. 20). Next, the user' S selection of the chart is accepted in the same manner as step S318, and the door (gate) corresponding to a certain door (gate) icon displayed in the door (gate) area BA1a1 selected by the user by clicking, touching, or the like is displayed in the chart selected in the chart display area BA 1B. The gate (gate) displayed in the graph can be moved in accordance with a selection and drag by the user, an operation on an arrow key of the keyboard, or the like. The processing unit 10 receives the position of the door (gate) specified by the user as the setting of the door (gate) (fig. 13-3, step S322). When the user completes setting all the charts, the processing unit 10 receives input of this information (fig. 13-3, step S323). When receiving the input of the information (Yes), the processing unit 10 temporarily stores the contents set for each graph in the memory 12 or automatically stores the contents in the auxiliary storage unit 13 in the storage unit when switching the label or switching the check item (panel) (step S324). When the input of this information is not completed, the process returns to step S3222 and further user selection of the chart and setting of the gate (gate) are accepted.
Next, the processing unit 10 measures the examination item management sample prepared by the user in the measurement unit 200, and accepts further adjustment by the user regarding the setting of each chart set in steps S322 to S329 (fig. 13-3, step S325). The user places the sample in the aspirating unit 21 of the measurement unit 200, and selects the measurement start icon B62 shown in fig. 22. The processing unit 10 receives a selection of the measurement start icon B62 by the user, and transmits a measurement start instruction to the measurement unit 200 via the I/F unit 15. The processing unit 10 receives information of the light signal detected by each light receiving element of the measuring unit 23 via the I/F unit 15. The processing unit 10 displays information on the received light signal as a graph according to the intensity of light and/or a graph according to the cell size on the graph corresponding to each light-receiving element in the graph display area BA1B (fig. 13-3, step S326, and fig. 22). The graph is preferably a scatter plot or a histogram. The user selects the drawing and readjusts the axes and/or gates (gates) while viewing each graph, and the processing unit 10 receives the selection of the graph and readjustment of the axes and/or gates (fig. 13-3, step S327). When the user completes setting all the charts, the processing unit 10 receives input of this information (fig. 13-3, step S328). When receiving the input of the information (Yes), the processing unit 10 temporarily stores the contents set for each graph in the memory 12 or automatically stores the contents in the storage unit in the auxiliary storage unit 13 when switching the label or switching the check item (panel) (step S329). If the input of this information is not completed, the process returns to step S326 to receive further user selection of the chart and setting of the gate (gate).
Seed and seed precision management (QC) file registration
After the registration process of the check item (panel) is completed, the processing unit 10 receives the registration of the Quality Control (QC) file by the user (fig. 1, step S4). Selection of the Quality Control (QC) icon B12 of fig. 22 by the user is accepted and a Quality Control (QC) file BQC0 (fig. 24) is displayed on the main interface B. Next, the processing unit 10 receives a user selection of the Quality Control (QC) file registration icon X3 in the Quality Control (QC) file operation region BQC1, and displays a Quality Control (QC) file registration dialog box X3DT shown in fig. 25 (fig. 23, step S401). The precision management (QC) file registration dialog box X3DT includes: a check item (panel) name drop-down list region X3DT1 that displays the name of a registered check item (panel), a comment display region X3DT2 that displays a comment attached to the registered check item (panel), a measurement item (subset panel) display region X3DT3 that displays a measurement item (subset panel) registered in the check item (panel), an archive icon X3DTE for specifying setting and closing a quality management (QC) file registration dialog X3DT, and an archive icon cancel X3DTC for closing the quality management (QC) file registration dialog X3DT without archiving the setting.
The pull-down list region X3DT1 displays a list of names of the check items (panel) set in the "registration of check items (panel)". The content input to the comment input region G1D3 of the check item management (panel master) registration dialog G1D is displayed in the comment display region X3DT 2.
The measurement item (subset panel) name input in step S308 of fig. 13 is displayed in the measurement item (subset panel) display region X3DT 3.
Next, as shown in fig. 26, the processing unit 10 receives a selection of the examination item (panel) name from the drop-down list of the examination item (panel) name by the user, and displays the measurement item (subsetpanel) list corresponding to the selected examination item (panel) name in the measurement item (subsetpanel) display area X3DT3 (fig. 23, step S402). The 1 measurement item (subset panel) list includes columns showing the position number (Pos.) of the reagent, the name of the measurement item (subset panel), the expiration date (expiration date) of the reagent, comments, and the like. The position number of the reagent, the expiration date of the reagent, the comment, and the like are input by receiving the input of the user, and the processing unit 10 receives the input (fig. 23 and step S402). In fig. 26, if the user selects the date mark in the reagent expiration date field or clicks on the date mark, a calendar is displayed, and a date can be selected from the calendar or the date can be directly input.
Next, the processing unit 10 accepts the determination of the user' S input, i.e., the selection of the archive icon X3DTE by the user (fig. 23, step S403), and closes the Quality Control (QC) file registration dialog box X3 DT. At this time, the processing unit 10 stores the content input by the user in the memory 12 or the auxiliary storage unit 13. Next, the processing unit 10 receives a selection of the measurement item (subsetpanel) selection icon X4 shown in fig. 24 by the user, and displays the baseline setting interface T shown in fig. 27 (fig. 23 and step S403).
Setting of seeds or seeds
The processing unit 10 performs setting of evaluation criteria for the fertility management and the like on the basis of measurement data obtained by measuring the test item management sample prepared in each test chamber by the particle analyzer 1000 in step S325 of fig. 13-3 on the baseline setting interface T. This setting is the setting processing of the base line in step S5 of fig. 1.
The baseline setting interface T shown in fig. 27 can display: a display region T1 of an inspection item (panel) name, a review display region T2 of the inspection item (panel), a display region T3 of a measurement item (subset panel), a review display region T4 of the measurement item (subset panel), a setting region (QCItem) T5 of each channel, a particle distribution display region T6, a list display region T61 of setting of a display upper gate (gate), a target MFI display region T62 of inputting a fluorescence intensity corresponding TO a voltage value, a fixed range setting region T63 of an evaluation criterion (Limit) of accuracy management, a region T64 of manually inputting an upper Limit (upper limited) of the evaluation criterion of accuracy management, a region T65 of manually inputting a lower Limit (LowerLimited) of the evaluation criterion of accuracy management, a determination (OK) cancel icon TO determine the setting, and a setting cancel icon TC TO suspend the setting. In the example shown in fig. 27, the list display area T61 and the fixed range setting area T63 for displaying the settings of the upper gate (gate) are displayed in the form of a pull-down list, but the user may accept input of characters. The statistical information can be input in the fixed range setting region T63. The statistical information is, for example, ± 1SD (SD is standard deviation), ± 2SD, ± 3SD, mean, median, cell number, etc.
In addition, in the setting region T5 of each channel, there are displayed so as to be switchable: PMT value/gain setting tag T51, compensation tag T52 for fluorescence correction, and Statistics tag T53. The labels of the respective labels have respective check boxes in the horizontal direction of the display such as "PMT value/gain", "compensation", and "statistics" that are selected by the user by clicking or touching the check boxes. The item of the tab selected by selecting the check box can be used as a management item for quality control. The PMT value/gain setting tag T51 includes: an Item (Item) area for selecting each channel (light receiving element), and a target area for selecting a management object (PMT value or rCV). The values set in the device Quality Control (QC) are displayed in the target area. Symbol T54 represents an icon selected by the user when adding a channel. SSC, FSC, FL4, FL1, FL5, FL8, FL6, FL2, and the like displayed in the Item (Item) area are character strings corresponding to the respective channels (light receiving elements). "H" represents a Hight value and "A" represents an Area value. The display of the Item (Item) area corresponds to the axis number of each chart displayed in the chart (plot) tag shown in fig. 20, and is displayed by the processing unit 10. Whether or not to be a management item for the accuracy management can be set for each tag unit by the user clicking a check box, or can be set for each 1 light-receiving element by the user selecting an option of the target area by double-clicking or the like.
In the particle distribution display region T6, the number of particles is shown on the vertical axis and the fluorescence intensity is shown on the horizontal axis, and the distribution of particles when the test item management sample is measured is displayed. A graph, preferably a histogram or a scattergram, corresponding to the intensity of light and/or a graph corresponding to the cell size is displayed in the particle distribution display region T6. In the particle distribution display area T6, the display by the histogram and the display by the scattergram can be switched. The particle distribution display area T6 shows each graph shown in a graph (plot) label BA10 shown in fig. 22. Fig. 27 is an example of a histogram showing the particle distribution. In this area, a peak range of a particle group to be managed is set at a gate (gate). The position and width of the gate (gate) can be adjusted by the user moving the T8 area with a mouse or the like.
The range in which the fluorescent signal is obtained is shown as a gate (gate) T8 in the particle distribution display region T6.
The information of the name of the examination item (panel) set in the above "registration of the examination item (panel)" is displayed in the display area T1 of the name of the examination item (panel). The content input to the comment input region G1D3 of the check item management (panel master) registration dialog G1D is displayed in the comment display region T2 of the check item (panel). The name of the measurement item (subset panel) input in step S308 of fig. 13 is displayed in the display region T3 for the name of the measurement item (subset panel). The comments accepted in the comment input region H1D3 shown in fig. 15 are displayed in the comment display region T4 of the measurement item (subset panel).
When the user selects the compensation tag T52, as shown in fig. 28, the processing unit 10 displays a table in which the light receiving element labels are arranged in the column direction and the row direction and a value indicating the fluorescence intensity is input, instead of displaying the Item (Item) area and the target area. When setting is performed for automatic fluorescence correction at the time of registration of an examination item (panel), the table shows values stored in the auxiliary storage unit 13 or the memory 14 by the processing unit 10 at the time of measurement of the management sample. The row direction represents the Area value and the column direction represents the detector. For example, a cell in row FL1 and column FL1 is shown with "100". This means that the light in the fluorescence wavelength region to be detected by the light-receiving element of FL1 is detected by the light-receiving element of FL1 at 100%. On the other hand, for example, a cell in the row FL2 and the column FL1 shows "4.1". This means that the light in the fluorescence wavelength region to be detected by the light-receiving element of FL2 was detected by the light-receiving element of FL1 at 4.1%. In this case, it means that correction is necessary to perform particle detection by combining FL1 and FL2, and the light quantity detected by the light receiving element of FL1 is reduced by 4.1% of the spectral quantity.
When the compensation (compensation) tab T52 is selected, the particle distribution display region T6 is switched to a graph display. When the compensation tag T52 is selected, only the upper gate (gate) can be selected in the example of fig. 28.
When the user selects the Statistics (Statistics) tab T53, the processing unit 10 indicates the statistical result of the gate (gate) in each chart set by measuring the management sample when the check item (panel) is registered, as shown in fig. 29. In the example of fig. 29, column 1 of the statistical result shows a label indicating the name of an Item (Item), for example, a measurement Item (Marker) of lymphocyte (Lymph), which is the name of a test Item (panel). The processing unit 10 displays the name corresponding to the gate (gate) of the chart (plot) tab BA10 shown in fig. 22 in the Item (Item) name. Lymph was shown as a CD3 positive (CD 3 +) and a CD3 negative (CD 3-) cohort. The CD3 + population is further classified into CD4 +/CD 8 +, CD4 +/CD 8-, CD 4-/CD 8 + and CD 4-/CD 8-depending on the type of lymphocyte. The CD 3-group is divided into CD19 +/CD 16 +, CD19 +/CD 16-, CD 19-/CD 16 + and CD 19-/CD 16-. The 2 nd column of the statistical results indicates the counted number of cells (# Count). For example, in the line Lymph, it means that 10,000 are counted. Line CD3 + means 8721 CD3 + in Lymph. In addition, CD4 +/CD 8 + means that there are 5102 CD4 +/CD 8 + cells in CD3 +. X _ rCV represents the variance of the fluorescence intensity on the X-axis. Y mean represents the arithmetic mean of the fluorescence intensity on the Y axis.
When the user selects the Statistics (Statistics) tab T53, a histogram or a scatter diagram corresponding to the Item (Item) is displayed in the particle distribution display area T6. Further, a fixed range setting region T63 of the evaluation criterion (Limit) of quality control for setting the evaluation criterion of quality control, a region T64 of the upper Limit (UpperLimited) of the evaluation criterion of quality control manually input, and a region T65 of the lower Limit (LowerLimited) of the evaluation criterion of quality control manually input are displayed. The processing unit 10 accepts user selection of these areas or input to these areas.
Setting of evaluation references for seed/seed precision management
The method of setting the baseline (setting of the evaluation criterion for quality control) shown in step S5 in fig. 1 will be described with reference to fig. 30-1 as an example.
In step S501 of fig. 30-1, the processing section 10 accepts user selection of a channel of the PMT gain (PMT/gain) tag T51. When PMT gain (PMT/gain) tag T51 is not selected, a user selection of PMT gain (PMT/gain) tag T51 is accepted and PMT gain (PMT/gain) tag T51 is displayed before step S501.
Next, the processing unit 10 displays the histogram or the scatter diagram corresponding to the selected channel (step S502).
Next, the processing unit 10 receives the user' S adjustment of the door (gate) T8 (step S503).
Next, the processing unit 10 accepts the user' S input or selection of the list display area T61 for displaying the setting of the upper gate (gate), the target MFI display area T62, and the fixed range setting area T63 or the area T64 for manually inputting the upper limit value (UpperLimited) and the area T65 for manually inputting the lower limit value (LowerLimited) (step S504). This step is an evaluation criterion setting step.
Next, when the user performs an operation indicating that all the settings have been completed, the processing unit 10 proceeds to the subsequent step as if all the channel settings have been completed (YES). If the user does not perform an operation indicating that all settings have been completed, the process returns to step S501 and receives a subsequent selection of a channel.
Next, after the PMT gain (PMT/gain) tab T51 is set, the user selects the compensation tab T52 to display the compensation tab T52 (fig. 30-2, step S506).
Next, the processing unit 10 receives a user selection of the Statistics (Statistics) tab T53, and displays a Statistics (Statistics) tab T53 (fig. 30-2, step S507).
Next, the processing unit 10 receives the user' S input or selection of the fixed range setting region T63, the region T64 in which the upper limit value (UpperLimited) is manually input, and the region T65 in which the lower limit value (LowerLimited) is manually input (fig. 30-2, step S508). This step is a step of setting an evaluation criterion based on the statistical value.
Next, the processing unit 10 accepts selection of the OK icon TO of the baseline setting interface T by the user (fig. 30-2, step S509). Upon receiving the selection of the OK icon TO, the processing unit 10 closes the baseline setting interface T and displays a Quality Control (QC) file registration dialog X3DT (fig. 30-2, step S509).
Next, the processing unit 10 receives a selection of the archive icon X3DTE of the Quality Control (QC) file registration dialog box X3DT by the user, and stores the setting of the evaluation criterion in the storage unit as data in a file format that can be derived by a program for controlling the operation of the particle analyzer 200 by the processing unit 10 in the daily Quality Control (QC) process described later. The processing unit 10 stores the setting of the evaluation criterion in the memory 12 or the auxiliary storage unit 13, and preferably stores the setting in the auxiliary storage unit 13 in a nonvolatile manner (fig. 30-2, step S510).
Next, the processing unit 10 displays a selection interface dialog S of the quality control method shown in fig. 31 on the display screen as the output unit 17 (step S511). a region S1 of the selection interface S is an example for allowing the user to select the quality control method.a Yes region S2 is a region for allowing the user to specify the selection, and a No region S3 is a region for accepting the selection for canceling the setting.when the user selects NotUpdate ○ of the region S1, the processing unit 10 closes the selection interface dialog S of the quality control method after accepting the selection of the Yes region S2 or the No region S3 by the user, and displays a main interface B including a Quality Control (QC) file BQC of fig. 32 (fig. 30-2, step S512).
Production of seeds and seeds reports
Next, the processing unit 10 performs the process of creating the report shown in step S6 in fig. 1. As shown in fig. 33, the processing unit 10 displays a Quality Control (QC) file of "6 CTBNK" in which an evaluation criterion for quality control is set in a Quality Control (QC) file operation region BQC 1. When the user selects a Quality Control (QC) file in the Quality Control (QC) file operation region BQC1, a list of measurement items (subset panels) is displayed in the list BQC 4. Here, a list of measurement items (subset panel) is shown, which is "CD 3/CD 4/CD 8/CD 16.". When the user selects the measurement item (subset panel) list and the processing unit 10 receives the process of selecting archivebutteronacb, the processing unit 10 displays a report on the report tag BA 20. The results of the user's selection by himself are displayed on the report label BA 20. For example, a sample information display area BA201, a chart display area BA202, a count result display area BA203, a measurer signature area BA204, and the like are displayed.
Preferably, in steps S1 to S5 shown in fig. 1, the access right of the user is limited. For example, it is preferable that the password input in the login interface L shown in fig. 5 is managed only by a user having an administrative authority. Thus, the set evaluation criterion for quality control can be prevented from being changed arbitrarily.
(method of controlling precision)
The control unit 100 performs quality control in daily inspections (also referred to as "daily Quality Control (QC)") using the evaluation criterion for quality control of each measurement item (subset panel) set in the above-described "setting of quality control of inspection items (QC)". In this case, the control unit 100 is a quality control device.
Seed and seed daily precision management (QC) processing
Step S7 of fig. 1, in which daily Quality Control (QC) is performed using the control samples prepared in the respective test chambers, will be described. Here, the setting of the evaluation criterion for quality control need not be performed before the Quality Control (QC) every day, and may be performed at a constant interval such as 1 time per week or 1 time per month, or when the lot of the detection reagent or the control sample is changed. The interfaces required for daily Quality Control (QC) are sometimes collectively referred to as quality control interfaces.
Fig. 34 shows a process flow of daily Quality Control (QC). Fig. 35 illustrates a login interface L when performing daily Quality Control (QC). Daily Quality Control (QC) can also be performed by users without authority, so the login interface L is not necessary. In step S701, the processing unit 10 receives a selection of a Quality Control (QC) icon B12 from the user.
Next, in step S702, as shown in fig. 36, the processing unit 10 displays a Quality Control (QC) file list region BQC0 and a measurement item (subset panel) list display region BQC 3.
Next, in step S703, the processing unit 10 accepts selection by the user of a Quality Control (QC) inspection item (panel) generated in the inspection item Quality Control (QC) setting process displayed in the Quality Control (QC) file list region BQC 0. Next, in step S704, the processing unit 10 accepts selection of a Quality Control (QC) icon X1 for displaying the content of a Quality Control (QC) file by the user.
Next, in step S705, the processing unit 10 displays a daily Quality Control (QC) dialog X1D shown in fig. 37. A daily quality management (QC) dialog X1D is displayed in the daily quality management (QC) dialog X1D: a start icon X1D1 for starting measurement, a measurement item (subset panel) list display area X1D2, a light-receiving element status display area X1D4, a confirm (OK) icon X1DE for confirming an input and advancing to a subsequent step, and a cancel icon X1DC for stopping a setting. The measurement item (subset panel) list display region X1D2 displays the measurement item (subset panel) list X1D 3. In addition, in the region displayed in the light-receiving element status display region X1D4, the voltage and variance of each light-receiving element (PMT) are displayed for each channel (rCV). The PMT voltage rCV includes a region for displaying the Target Value (Target) and a region for displaying the actual measurement Value (Value). The predetermined target value is displayed in the area where the target value is displayed. The user places the device management sample in the aspirating unit 21 of the particle analyzer 1000 after step S705 or before step S705.
In step S706, the processing unit 10 displays the PMT voltage values of the respective channels when the device management sample being measured is measured and rCV calculated by the processing unit 10 as shown in fig. 38, and receives a selection of the start icon X1D1 from the user to start measurement of the device management sample. After the start of measurement, as shown in fig. 23, the PMT voltage is automatically set so that the PMT voltage becomes a value near the target value for each measurement item. After the PMT voltage is set, the determination icon X1DE can be selected. The processing unit 10 receives a selection of the determination icon X1DE from the user, and closes the daily Quality Control (QC) dialog X1D.
Next, the user places the examination item management sample prepared in the examination room in the aspirating unit 21. The processing unit 10 starts measurement of the examination item management sample prepared in the examination room in response to the measurement start instruction input by the user (step S707). After the measurement is completed, the processing unit 10 outputs the result of the accuracy control (step S708). The result of the quality control may be displayed as a numerical value or may be graphically represented by a chart or the like. The graph can exemplify a graph (e.g., a radar graph) developed by several axes with each channel as an axis. The graphs can exemplify time-series graphs such as Xbar-R management graphs (Levey-jenningscharts: L-Jcharts) and Xbar-Rs-R management graphs for the respective channels. Each channel may also be divided into PMT voltage values and/or rCV values for each channel. The result of the quality control can be displayed every time the daily Quality Control (QC) is performed.
A graph developed by several axes is preferred because it enables several axes to be displayed in one interface for 1-time daily Quality Control (QC) results. In addition, since the time-series chart is displayed together with the past quality control results at least 1 time point, the fluctuation within one day and the fluctuation between days can be monitored. The quality control interface for displaying the quality control result may include a region for displaying at least the quality control result for each test item and the evaluation criterion for each test item.
For example, the output unit 17 outputs to the display for each channel as shown in fig. 39. Fig. 39 is an example of a radar chart label BQC6 of the region BQC5 showing the measurement results of the inspection item management samples on the left. The measurement results of the test item management samples are displayed as a Radar chart. Fig. 40 shows a radar chart with each channel as an axis. The meaning of the lines shown in each Radar is illustrated in fig. 41. LowerLimit represents a lower limit of the management limit. UpperLimit represents an upper limit of the management limit. The graph shows an actual measured value, and Target shows a Target value. FL1 and FL2 denote the respective channels. Each axis of the radar chart indicates each detection object in each channel. The number of axes of the radar chart is not limited, and is preferably about 3 to 6 to be able to recognize the displayed characters. By displaying the quality control data in this manner, the user can easily grasp which channel has a problem, in the event of a quality control failure.
FIG. 42 is a display example of an L-J chart label BJC 7, FIG. 43 is an enlarged view of an L-J chart label BJC 7, in an L-J chart label BJC 7, measurement data of each management sample is plotted in time series together with a management limit for each management sample, and a user can grasp a change in analysis accuracy at a glance.an item display area LJJ 1 for displaying a channel object item name corresponding to each graph, a chart display area LJ2 for displaying an accuracy management chart (preferably an Xbar-R management chart), and an icon Y1 for displaying details of each graph, an icon Y2 for deleting a chart from a chart, an icon Y3. for inserting comment, are displayed in more detail using FIG. 44 for displaying a value in the L-J chart label BJC 7, each graph measurement can correspond to 1 time of an accuracy management measurement, a CS cursor is made to correspond to 1 time of the accuracy management chart, and a cursor for inserting a comment indicates that a measurement data is displayed in a case where a cursor is shifted from a point of the accuracy management chart, and a point of the measurement data is changed when the accuracy management chart is displayed by a cursor on the index of a CS 7, and a point of the accuracy management chart is changed, and the point of the accuracy management chart is displayed in time management chart, and the point when the point of the point is changed, it is displayed in the point of the.
In the L-J chart tab BQC7, the precision management data of the date and time desired by the user can be viewed by matching the cursor CS with the position desired by the user.
The user confirms the displayed accuracy management result, and when the accuracy management is good, the accuracy management is finished. The method of displaying the comment of the defective accuracy control is not limited to the above. The display method such as changing the color of the chart determined as having poor accuracy control, changing the shape of the drawing symbol, and displaying the exclamation mark can be selected.
Output of seed and seed reports
Next, the processing unit 10 performs the process of creating the report shown in step S8 in fig. 1. As shown in fig. 45, the processing unit 10 displays a Quality Control (QC) file of "6 CTBNK" in which an evaluation criterion for quality control is set in a Quality Control (QC) file operation region BQC 1. When the user selects a Quality Control (QC) file in the Quality Control (QC) file operation region BQC1, a list of measurement items (subset panels) is displayed in the list BQC 4. Here, a list of measurement items (subset panel) is shown, which is "CD 3/CD 4/CD 8/CD 16.". When the user selects the measurement item (subset panel) list, the processing unit 10 receives the selection of the selection acceptance button (archive button) AcB, and the processing unit 10 displays a report on the report tab BA 20. The report tab BA20 shows the results the user has selected at his or her discretion. For example, a sample information display area BA201, a chart display area BA202, a count result display area BA203, a measurer signature area BA204, and the like are displayed. Is displayed. Further, the processing unit 10 receives a selection of the lead-out icon EX by the user, and outputs a report to the output unit 17.
(measurement of measurement sample)
After the end of the daily Quality Control (QC), in step S9 shown in fig. 1, the processing unit 10 shows the specific processing in step S8 in fig. 48. In step S801, the processing unit 10 accepts selection of the Main (Main) icon B11 of the Main interface B shown in fig. 6 by the user. Fig. 46 shows a Main interface B displayed by the processing unit when the Main (Main) icon B11 is selected. The examination item (panel) list shows registered examination items (panel) "6 CTBNK". Next, in step S802, the processing unit 10 receives a selection of a registered examination item (panel) by the user, and displays the particle analysis condition setting region B3 shown in fig. 6. In step S803, the processing unit 10 receives an input of the measurement condition from the user to the particle analysis condition setting region B3. The processing unit 10 receives input of information on the measurement sample from the user in the analysis operation region B6 shown in fig. 6. Next, the user places the measurement sample 29 in the aspirating unit 21, and selects the measurement start icon B62 in the analysis operation region B6 shown in fig. 6. The processing unit 10 receives the selection and starts the measurement process. The processing unit 10 may automatically terminate the measurement after a fixed number of cells have been measured, or may terminate the measurement by the user selecting the measurement stop icon B63 in the analysis operation area B6 shown in fig. 6. After the analysis, the measurement results are displayed on a chart (plot) label BA10 as shown in fig. 47.
[ computer program ]
Other embodiments of the present disclosure relate to a computer program for causing a computer to execute steps S301 to S329 shown in fig. 13-1 to 13-3 and steps S401 to S403 shown in fig. 23, steps S501 to S513 shown in fig. 30-1 and 30-2, steps S701 to S708 shown in fig. 34, or steps S801 to S807 shown in fig. 48. The computer program is application software of the particle analysis apparatus 1000.
Further, an embodiment of the present disclosure relates to a program product such as a storage medium storing the assist program. That is, the computer program is stored in a semiconductor memory device such as a hard disk or a flash memory, or a storage medium such as an optical disk. The storage format in which the program is stored in the storage medium is not particularly limited as long as it is satisfied that the presentation means can read the program. The storage to the storage medium is preferably non-volatile. The storage medium may be provided as a program product.
[ other forms ]
In the above embodiment, the mode in which the control sample and the measurement sample are placed in the aspirating unit 21 has been described, and for example, as for the control sample and the measurement sample, the particles and the detection reagent may be mixed in the sample preparation apparatus, and the prepared substances may be placed in the particle analyzer 1000 for measurement, respectively, in accordance with the sample rack.
The following are different modes of setting of inspection items (panel) and/or daily Quality Control (QC): the processing unit 10 of the measurement apparatus 1000 acquires display mode information corresponding to a control sample, and displays a quality control setting interface or a quality control interface of the inspection item corresponding to the acquired display mode information on the display unit 17 so as to be switchable to a quality control setting interface or a quality control interface corresponding to other display mode information.
The test item control sample may include a control sample of an in vitro diagnostic reagent or a control sample prepared using a research reagent. Many of the control samples for in vitro diagnostic reagents are supplied from a supply source for the control samples and a supply source for the measurement device. In this case, the evaluation criterion is also provided together with the control sample for in vitro diagnosis. Therefore, the evaluation criterion for managing the accuracy control of the sample using the reagent for in vitro diagnosis, for example, preinstall, can be acquired from the auxiliary storage unit 13 or the processing unit 10 via the communication unit 151 from the network 99. On the other hand, a control sample prepared using a research reagent does not provide evaluation criteria like a control sample of an in vitro diagnostic reagent, and therefore requires a user to set the evaluation criteria. Therefore, in the case of setting the examination item (panel) and/or daily Quality Control (QC) using the control sample of the in vitro diagnostic reagent, and in the case of setting the examination item (panel) and/or daily Quality Control (QC) using the control sample prepared using the research reagent, the display modes of the quality control setting interface and the quality control interface may differ. The processing unit 10 acquires information corresponding to the management sample. The information corresponding to the control sample may include information for specifying a reagent (a reagent name, a reagent identification number, or the like), a lot number, a lifetime, display pattern information, and the like. The display mode information may include information on whether the control sample is a control sample for the in vitro diagnostic reagent or a control sample prepared using a reagent for study. The display of the precision management setting interface and the precision management interface can be switched by acquiring the display mode information. The display mode information may be acquired by the processing section 10 as information input by the user from the input section 16. The following steps can be also included: the display mode information is attached as a barcode to a package or a container of the detection reagent, and the barcode is read by a reading device connected to the control unit 100 and the information is read by the processing unit 10. The processing unit 10 may acquire the display mode information of preinstall in the auxiliary storage unit 13, or may acquire the display mode information from the network 99 via the communication unit 151.
Description of the symbols
1000 measuring apparatus
200 measurement cell
10 treatment section
17 output unit
16 input unit
12 memory
13 auxiliary storage part
21 suction unit
Claims (57)
1. A measurement device is provided with:
a measurement unit for measuring a management sample for performing quality control;
a display unit;
a processing unit that displays an input interface for setting an evaluation criterion used for the quality control on the display unit;
wherein the processing unit displays a result of the accuracy management of the inspection item on a display unit based on the measurement result of the management sample and the evaluation criterion.
2. The assay device according to claim 1, wherein:
the evaluation criterion is set according to the examination item.
3. The assay device according to claim 1, wherein:
the evaluation criterion is set by a user.
4. The assay device according to any one of claims 1 to 3, wherein:
the evaluation device further includes a storage unit that stores the evaluation criterion in a format that can be read by the processing unit.
5. The assay device according to any one of claims 1 to 3, wherein:
the evaluation device further comprises an input unit for setting the evaluation criterion on the input interface.
6. The assay device according to any one of claims 1 to 3, wherein:
the test item corresponds to a cell to be measured.
7. The assay device according to any one of claims 1 to 3, wherein:
the inspection items include 1 or more measurement items, and the evaluation criterion is set for each measurement item.
8. The assay device according to claim 7, wherein:
the measurement items include detection items corresponding to 2 or more types of target molecules to be detected that are individually detected by different light receiving elements.
9. The assay device according to claim 8, wherein:
the target molecule is an antigen.
10. The assay device according to claim 8 or 9, wherein:
the evaluation criterion is determined based on the intensity of light of each light receiving element when the control sample is measured.
11. The assay device according to claim 8 or 9, wherein:
the evaluation criterion was set based on a particle distribution map developed from the intensities of light of 2 measurement items.
12. The assay device according to claim 10, wherein:
the evaluation criterion is set based on a fixed door.
13. The assay device according to claim 12, wherein:
the door is set by the user.
14. The assay device according to any one of claims 1 to 3, wherein:
the evaluation criterion includes upper and lower limits of the intensity of light or particle size.
15. The assay device according to claim 12 or 13, wherein:
the evaluation criterion is set based on statistical information.
16. The assay device according to claim 15, wherein:
the statistical information is selected from the number of cells within the gate, the median of the intensity of the light, the average of the intensity of the light, or the standard deviation of the intensity of the light.
17. The assay device according to any one of claims 1 to 3, wherein:
and displaying an input area for accepting the characters input by the user on the input interface.
18. The assay device according to any one of claims 1 to 3, wherein:
and displaying the icon for accepting the user selection on the input interface.
19. The assay device according to any one of claims 1 to 3, wherein:
and displaying a drop-down list for accepting user selection on the input interface.
20. The assay device according to any one of claims 1 to 3, wherein:
and displaying the histogram or the scatter diagram on the input interface.
21. The assay device according to any one of claims 1 to 3, wherein:
the character string corresponding to each light receiving element is displayed on the input interface.
22. The assay device according to claim 10, wherein:
the light is fluorescent and/or scattered light.
23. The assay device according to claim 22, wherein:
when the light is fluorescence and there are several light receiving elements having sensitivity to 1 type of fluorescence, the processing unit further sets a fluorescence correction condition for adjusting the sensitivity of the several light receiving elements when setting the evaluation criterion.
24. The assay device according to any one of claims 1 to 3, wherein:
the assay device is a flow cytometer.
25. The assay device according to any one of claims 1 to 3, wherein:
the results of the quality control are displayed each time a control sample for each quality control is measured.
26. The assay device according to claim 25, wherein:
the result of the quality control is a result of the quality control for each channel, and is displayed in a graph developed with a plurality of channels as axes.
27. The assay device according to claim 25, wherein:
the result of the quality control is displayed together with the result of the quality control at a point in time performed in the past.
28. The assay device according to claim 27, wherein:
the results of the quality management are shown in a time series chart.
29. The assay device according to claim 25, wherein:
when the result of the quality control is bad, a warning is displayed together with the result of the quality control.
30. A method for managing accuracy, characterized by:
comprises the following steps:
a display step of displaying an input interface for setting evaluation criteria of the inspection items,
A measurement step of measuring a control sample for quality control based on the evaluation criterion,
And an output step of outputting a result of quality control of the control sample measured in the measurement step.
31. The accuracy management method according to claim 30, wherein:
the evaluation criterion is set according to the examination item.
32. The accuracy management method according to claim 30 or 31, wherein:
the evaluation criterion is set by a user.
33. The accuracy management method according to claim 31, wherein:
the inspection items include 1 or more measurement items, and the evaluation criterion is set for each measurement item.
34. The accuracy management method according to claim 33, wherein:
the measurement items include detection items corresponding to 2 or more types of target molecules to be detected that are individually detected by different light receiving elements.
35. The accuracy management method according to claim 30 or 31, wherein:
the evaluation criterion is determined based on the intensity of light measured by each light receiving element.
36. The accuracy management method according to claim 30 or 31, wherein:
the evaluation criterion was set based on a particle distribution map developed from the intensities of light of 2 measurement items.
37. The accuracy management method according to claim 36, wherein:
the evaluation criterion is set based on a certain threshold.
38. The accuracy management method according to claim 30 or 31, wherein:
the evaluation criterion includes an upper limit value and a lower limit value of the intensity of light or the size of the particle.
39. The accuracy management method according to claim 37, wherein:
the evaluation criterion is set based on statistical information.
40. The accuracy management method according to claim 30 or 31, wherein:
and displaying the histogram or the scatter diagram on the input interface.
41. The accuracy management method according to claim 35, wherein:
the light is fluorescent and/or scattered light.
42. The accuracy management method according to claim 30 or 31, wherein:
in the measurement step, the control sample is detected by a flow cytometer.
43. The accuracy management method according to claim 30 or 31, wherein:
in the output step, the result of the quality control is displayed each time the control sample for each quality control is measured.
44. The accuracy management method according to claim 30 or 31, wherein:
in the output step, the result of the quality control is displayed on a graph developed with a plurality of channels as axes.
45. The accuracy management method according to claim 43, wherein:
in the output step, the result of the quality control is displayed in a time-series chart.
46. An assay device, characterized by:
the disclosed device is provided with:
a measurement section for measuring a control sample for performing accuracy control,
A display part,
A processing unit for displaying the result of the quality control of the inspection item on the display unit,
the processing unit acquires information corresponding to a control sample, and displays a quality control setting interface or a quality control interface of the corresponding inspection item on the display unit based on the acquired information.
47. The assay device according to claim 46, wherein:
the information corresponding to the control sample is display mode information corresponding to the control sample, and the quality control setting interface or the quality control interface of the inspection item corresponding to the acquired display mode information is displayed on the display unit so as to be capable of being matched with the quality control setting interface or the quality control interface corresponding to the other display mode information.
48. The assay device according to claim 46 or 47, wherein:
the processing unit reads reagent information from a barcode attached to an inspection reagent container or a package, and displays a quality control setting interface or a quality control interface of an inspection item corresponding to the display mode information on the display unit.
49. The assay device according to claim 46 or 47, wherein:
the processing unit acquires reagent information through input by an input unit or from a network, and displays a quality control setting interface or a quality control interface of an inspection item corresponding to the display mode information on the display unit.
50. The assay device according to claim 46 or 47, wherein:
the control sample is a control sample of a reagent for in vitro diagnosis or a control sample prepared using a reagent for study,
the display mode information includes information on whether the control sample is a control sample of the in vitro diagnostic reagent or a control sample prepared using a research reagent.
51. The assay device according to claim 50, wherein:
when a control sample prepared by using a reagent for investigation is used as the control sample, the processing unit displays an interface for setting an evaluation criterion,
when a control sample of the in vitro diagnostic reagent is used as the control sample, the processing unit displays an interface in which evaluation criteria are set.
52. A method for managing accuracy, characterized by:
the method comprises the following steps:
a step of acquiring information corresponding to the control sample,
A display step of displaying a quality control setting interface or a quality control interface of the inspection item corresponding to the control sample,
A measurement step of measuring a control sample for controlling the accuracy,
And an output step of outputting a result of quality control of the control sample measured in the measurement step.
53. The accuracy management method according to claim 52, wherein:
the information corresponding to the control sample is display mode information corresponding to the control sample, and the quality control setting interface or the quality control interface of the inspection item corresponding to the acquired display mode information is displayed on the display unit so as to be switchable with the quality control setting interface or the quality control interface corresponding to the other display mode information.
54. The accuracy management method according to claim 52 or 53, wherein:
in the acquisition step, reagent information is acquired from a barcode attached to an inspection reagent container or a package, and in the display step, a quality control setting interface or a quality control interface of an inspection item corresponding to the display mode information is displayed on the display unit.
55. The accuracy management method according to claim 52 or 53, wherein:
in the acquisition step, the reagent information is acquired by an input from an input unit or from a network, and in the display step, a quality control setting interface or a quality control interface of the inspection item corresponding to the display mode information is displayed on the display unit.
56. The accuracy management method according to claim 52 or 53, wherein:
the control sample is a control sample of a reagent for in vitro diagnosis or a control sample prepared using a reagent for study,
the display mode information includes information on whether the control sample is a control sample of the in vitro diagnostic reagent or a control sample prepared using a research reagent.
57. The accuracy management method according to claim 54, wherein:
when a control sample prepared by using a reagent for investigation is used as the control sample, an accuracy control setting interface for setting an evaluation criterion is displayed in the display step,
when a control sample of the in vitro diagnostic reagent is used as the control sample, a precision control interface in which evaluation criteria are set is displayed in the display step.
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| JP2018-185295 | 2018-09-28 | ||
| JP2018185295A JP7352340B2 (en) | 2018-09-28 | 2018-09-28 | Measuring device and accuracy control method |
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| JP2020085535A (en) * | 2018-11-19 | 2020-06-04 | アークレイ株式会社 | Information processing device, measurement system, and program |
| CN116324375A (en) * | 2020-10-12 | 2023-06-23 | 索尼集团公司 | Biological microparticle sorting device, biological microparticle sorting system, and information processing device |
| WO2022080102A1 (en) * | 2020-10-12 | 2022-04-21 | ソニーグループ株式会社 | Server system, information processing system, data acquisition client terminal, data analysis client terminal, and information processing method |
| CN112730203B (en) * | 2020-12-29 | 2023-06-16 | 深圳市科曼医疗设备有限公司 | Optical system, optical gain calibration method, and storage medium for blood cell analyzer |
| JP7307758B2 (en) * | 2021-03-04 | 2023-07-12 | シスメックス株式会社 | SAMPLE ANALYSIS SYSTEM CONTROL METHOD AND SAMPLE ANALYSIS SYSTEM |
| WO2023017641A1 (en) * | 2021-08-13 | 2023-02-16 | ソニーグループ株式会社 | Bioparticle sorting device, bioparticle sorting system, and information processing device |
| WO2023074428A1 (en) * | 2021-10-29 | 2023-05-04 | ソニーグループ株式会社 | Biological particle isolating device and program |
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| JP2023165029A (en) | 2023-11-14 |
| US20200103333A1 (en) | 2020-04-02 |
| EP3629002A1 (en) | 2020-04-01 |
| JP7352340B2 (en) | 2023-09-28 |
| JP2020056593A (en) | 2020-04-09 |
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